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出境医 / 临床实验 / Project Arthritis Recovering Quality of Life Through Education - Hip

Project Arthritis Recovering Quality of Life Through Education - Hip

Study Description
Brief Summary:

Introduction: One in four people are at risk of developing symptomatic hip OAH. Perhaps the greatest potential for improvement in OAH treatment is to approach the early stages of pathology, since total hip arthroplasty was considered 20th century surgery, with high cost-effectiveness in patients who are not responding to clinical treatment.

Joint lavage with saline shows significant pain relief in patients with knee and hip OA. In addition, when the saline solution is injected under pressure, it can generate a hydraulic distension of the capsule, increasing the joint amplitude and increasing the effect of drugs injected after washing. Injection of corticosteroids (CS) is recognized for improving the effects of joint washing, pain and even viscosupplementation.

In the investigators experience, lavage and infiltration of triamcinolone, lidocaine with or without hyaluronic acid led to subjective-functional improvement and range of motion of the majority of patients with OAH grades 2 and 3 of K & L undergoing the procedure. Intra-articular injection of hyaluronic acid (HA) is analgesic and anti-inflammatory in addition to promoting better distribution of forces, lowering pressure by weight and recovering the viscoelastic properties of synovial fluid, i.e., mechanical effects. In previous studies by the investigators, the addition of hilano to the lavage and injection of triamcinolone and local anesthetic led to gains in joint amplitude that were maintained over a year.

Objective: To evaluate whether lavage followed by injection of triamcinolone, ropivacaine and 4 mL of hylan in the affected joint (Hilano) improves function, range of motion, pain, quality of life and muscle strength in patients with OAH in the early stages METHODS: 48 patients from the public network attended by the Orthopedics and Traumatology Institute of the General Hospital of the Medical School of the University of São Paulo, already identified with bilateral OA of the hip submitted to THR in one limb and the other limb presenting OA mild or moderate with indication of non-surgical treatment will be submitted to lavage, saline infiltration and CS (control group) or lavage, saline infiltration, CS and Hilano. Patients will be assessed at 1, 3, 6 and 12 months after the procedure using standardized questionnaires (WOMAC and Lequesne), quality of life scales (Euroqol-EQ-5D-5L), pain, range of motion and strength using an isokinetic dynamometer.


Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Behavioral: Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine Behavioral: Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine, Not Applicable

Detailed Description:

Hip OA (OAH) is less frequent than that of the hand and knee OA. One in four people have the risk of developing symptomatic OA of the hip.

Most guidelines for OAQ treatment combine recommendations for the treatment of knee and hip OA although OAH has specific etiopathogenic characteristics with its implications for individual therapeutic approaches.

Perhaps the greatest potential for improvement in OAH treatment is to approach the early stages of pathology, since total hip arthroplasty was considered to be 20th-century surgery with high cost-effectiveness in patients who are not responding to the clinical treatment of OA.

Measures that decrease inflammation and release capsular retraction leading to symptoms of pain and restriction of joint amplitude may improve the quality of life of these patients in the earliest stages of the disease.

Joint lavage with saline shows significant relief of pain in patients with knee and hip OA, probably by intra-articular removal of debris and factors that cause irritation and inflammation. In addition, when the saline solution is injected under pressure, it can generate a hydraulic distension of the capsule, increasing the joint amplitude and increasing the effect of drugs injected after washing. Injection of corticosteroids (CS) is recognized for improving the effects of joint washing, pain and even viscossuplementation.

In our experience, lavage and infiltration of triamcinolone, lidocaine with or without hyaluronic acid led to subjective-functional improvement and range of motion of most patients with OAH grades 2 and 3 of Kellgren and Lawrence undergoing the procedure.

The viscossuplementation of the hip has not yet been established in regard to type, dose, indication or frequency, and the number of existing jobs is relatively small in relation to those performed on knee osteoarthritis (OAK). Intra-articular injection of hyaluronic acid (HA) is analgesic and anti-inflammatory in addition to promoting better distribution of forces, lowering pressure by weight and recovering the viscoelastic properties of synovial fluid, i.e., mechanical effects. Its prolonged effect is explained by the action of hyaluronic acid on the CD44 receptors of synoviocytes and by the reduction of activated serum T cell levels. In our experience, the addition of hilano to the lavage and injection of triamcinolone and local anesthetic led to gains in joint amplitude that were maintained over a year.

Thus, the investigators developed a study to improve the range of motion and the function of patients with mild to moderate OA of the hip through lavage with physiological saline and hydraulic distension comparing to lavage, hydraulic distension and CS injection, anesthetic and a dose of 4mL of G-F20 hilano.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Project Arthritis Recovering Quality of Life Through Education - Hip
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Experimental
24 patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 3mL of hylan, 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.
 Behavioral: Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine

Patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 3mL of hylan, 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.

Answer: WOMAC, Lequesne, VAS, EQ-5D-5L at inclusion, one week prior to surgery, 1st, 3rd, 6th and 12th months postoperatively.

Submitted to evaluaton in the isokinetic dynamometer (Cybex 6000, Ronkokoma Lumex Inc.) where de amplitudes of movement of hip flexion, extension, abduction and adduction will be measures. Hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees/second.

Costs will be evaluated for cost-effectiveness and cost-utility analysis.
Active Comparator: Control Group
24 patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine
 Behavioral: Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine,

Patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.

Answer: WOMAC, Lequesne, VAS, EQ-5D-5L at inclusion, one week prior to surgery, 1st, 3rd, 6th and 12th months postoperatively.

Submitted to evaluaton in the isokinetic dynamometer (Cybex 6000, Ronkokoma Lumex Inc.) where de amplitudes of movement of hip flexion, extension, abduction and adduction will be measures. Hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees/second.

Costs will be evaluated for cost-effectiveness and cost-utility analysis.
Outcome Measures
Primary Outcome Measures :
  1. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and ropivacaine improves range of flexion in the 3rd postoperative month in respect to lavage e triamcinolone injection. [ Time Frame: 3 months ]
    Evaluate amplitudes of movement of hip flexion, extension, abduction and adduction; the hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees / second.


Secondary Outcome Measures :
  1. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Range of flexion, Range of motion (extension, adduction and abduction), Strength of flexion, extension, adduction e abduction. [ Time Frame: 1 month, 6 months and 12 months ]
    Evaluate amplitudes of movement of hip flexion, extension, abduction and adduction; the hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees / second.

  2. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Womac [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Womac questionnaire (Range minimum 0 - range maximum 96)

  3. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Lequesne [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Lequesne questionnaire (Range minimum 0 - range maximum 24)

  4. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: VAS [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Visual Analogue Scale (Range minimum 0 - range maximum 100)

  5. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: EuroQol Questionnaire [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer EuroQol questionnaire

  6. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine increases Lean Mass Percentage [ Time Frame: 1 month, 6 months and 12 months ]
    Calculate lean mass of all patients

  7. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine decrease fat percentage [ Time Frame: 1 month, 6 months and 12 months ]
    Calculate fat percentage of all patients


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women diagnosed with bilateral OAH with or without comorbidities (metabolic syndrome, i.e. OA + at least two of overweight / central obesity, diabetes, dyslipidemia, hypertension)
  • Age between 60 and 75 years who are awaiting primary THR, with indication of non-surgical treatment in the contralateral limb
  • Patients without previous arthroplasties in the lower limbs.
  • Patients with no personal history of chronic inflammatory arthritis (rheumatoid arthritis, for example).
  • Patients with no personal history of cognitive, psychiatric and / or neurological disorders, whose symptoms presented at the time of evaluation are related or significantly interfere with the functions of attention, memory, logical reasoning, comprehension, in order to impair the assimilation of the given guidelines.
  • Patients able to read, understand and respond to questionnaires and perform functional tests.

Exclusion Criteria:

  • Fail to intervene and not perform the tasks determined by the professionals.
  • Patients diagnosed during the study with chronic inflammatory arthritis (rheumatoid arthritis, for example)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Livia Abreu 1126612473 murmedicina@outlook.com

Locations
Layout table for location information
Brazil
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Guilherme Ocampos, MD University of São Paulo General Hospital
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date July 29, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2019) 		Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and ropivacaine improves range of flexion in the 3rd postoperative month in respect to lavage e triamcinolone injection. [ Time Frame: 3 months ]
Evaluate amplitudes of movement of hip flexion, extension, abduction and adduction; the hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees / second.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and ropivacaine improves range of flexion in the 3rd postoperative month in respect to lavage e triamcinolone injection. [ Time Frame: 3 months ]
All patients will be submitted to the evaluation in the isokinetic dynamometer (Cybex 6000, Ronkonkoma Lumex Inc.) where the amplitudes of movement of hip flexion, extension, abduction and adduction will be evaluated; the hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees / second.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Range of flexion, Range of motion (extension, adduction and abduction), Strength of flexion, extension, adduction e abduction. [ Time Frame: 1 month, 6 months and 12 months ]
    Evaluate amplitudes of movement of hip flexion, extension, abduction and adduction; the hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees / second.
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Womac [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Womac questionnaire (Range minimum 0 - range maximum 96)
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Lequesne [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Lequesne questionnaire (Range minimum 0 - range maximum 24)
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: VAS [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Visual Analogue Scale (Range minimum 0 - range maximum 100)
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: EuroQol Questionnaire [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer EuroQol questionnaire
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine increases Lean Mass Percentage [ Time Frame: 1 month, 6 months and 12 months ]
    Calculate lean mass of all patients
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine decrease fat percentage [ Time Frame: 1 month, 6 months and 12 months ]
    Calculate fat percentage of all patients
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Range of flexion, Range of motion (extension, adduction and abduction), Strength of flexion, extension, adduction e abduction. [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will be submitted to the evaluation in the isokinetic dynamometer (Cybex 6000, Ronkonkoma Lumex Inc.) where the amplitudes of movement of hip flexion, extension, abduction and adduction will be evaluated; the hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees / second.
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Womac [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Womac questionnaire
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Lequesne [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Lequesne questionnaire
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: VAS [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Visual Analogue Scale (VAS)
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: EuroQol Questionnaire [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer EuroQol questionnaire
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine increases Lean Mass Percentage [ Time Frame: 1 month, 6 months and 12 months ]
    Calculate lean mass of all patients
  • Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine decrease fat percentage [ Time Frame: 1 month, 6 months and 12 months ]
    Calculate fat percentage of all patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project Arthritis Recovering Quality of Life Through Education - Hip
Official Title  ICMJE Project Arthritis Recovering Quality of Life Through Education - Hip
Brief Summary

Introduction: One in four people are at risk of developing symptomatic hip OAH. Perhaps the greatest potential for improvement in OAH treatment is to approach the early stages of pathology, since total hip arthroplasty was considered 20th century surgery, with high cost-effectiveness in patients who are not responding to clinical treatment.

Joint lavage with saline shows significant pain relief in patients with knee and hip OA. In addition, when the saline solution is injected under pressure, it can generate a hydraulic distension of the capsule, increasing the joint amplitude and increasing the effect of drugs injected after washing. Injection of corticosteroids (CS) is recognized for improving the effects of joint washing, pain and even viscosupplementation.

In the investigators experience, lavage and infiltration of triamcinolone, lidocaine with or without hyaluronic acid led to subjective-functional improvement and range of motion of the majority of patients with OAH grades 2 and 3 of K & L undergoing the procedure. Intra-articular injection of hyaluronic acid (HA) is analgesic and anti-inflammatory in addition to promoting better distribution of forces, lowering pressure by weight and recovering the viscoelastic properties of synovial fluid, i.e., mechanical effects. In previous studies by the investigators, the addition of hilano to the lavage and injection of triamcinolone and local anesthetic led to gains in joint amplitude that were maintained over a year.

Objective: To evaluate whether lavage followed by injection of triamcinolone, ropivacaine and 4 mL of hylan in the affected joint (Hilano) improves function, range of motion, pain, quality of life and muscle strength in patients with OAH in the early stages METHODS: 48 patients from the public network attended by the Orthopedics and Traumatology Institute of the General Hospital of the Medical School of the University of São Paulo, already identified with bilateral OA of the hip submitted to THR in one limb and the other limb presenting OA mild or moderate with indication of non-surgical treatment will be submitted to lavage, saline infiltration and CS (control group) or lavage, saline infiltration, CS and Hilano. Patients will be assessed at 1, 3, 6 and 12 months after the procedure using standardized questionnaires (WOMAC and Lequesne), quality of life scales (Euroqol-EQ-5D-5L), pain, range of motion and strength using an isokinetic dynamometer.
Detailed Description

Hip OA (OAH) is less frequent than that of the hand and knee OA. One in four people have the risk of developing symptomatic OA of the hip.

Most guidelines for OAQ treatment combine recommendations for the treatment of knee and hip OA although OAH has specific etiopathogenic characteristics with its implications for individual therapeutic approaches.

Perhaps the greatest potential for improvement in OAH treatment is to approach the early stages of pathology, since total hip arthroplasty was considered to be 20th-century surgery with high cost-effectiveness in patients who are not responding to the clinical treatment of OA.

Measures that decrease inflammation and release capsular retraction leading to symptoms of pain and restriction of joint amplitude may improve the quality of life of these patients in the earliest stages of the disease.

Joint lavage with saline shows significant relief of pain in patients with knee and hip OA, probably by intra-articular removal of debris and factors that cause irritation and inflammation. In addition, when the saline solution is injected under pressure, it can generate a hydraulic distension of the capsule, increasing the joint amplitude and increasing the effect of drugs injected after washing. Injection of corticosteroids (CS) is recognized for improving the effects of joint washing, pain and even viscossuplementation.

In our experience, lavage and infiltration of triamcinolone, lidocaine with or without hyaluronic acid led to subjective-functional improvement and range of motion of most patients with OAH grades 2 and 3 of Kellgren and Lawrence undergoing the procedure.

The viscossuplementation of the hip has not yet been established in regard to type, dose, indication or frequency, and the number of existing jobs is relatively small in relation to those performed on knee osteoarthritis (OAK). Intra-articular injection of hyaluronic acid (HA) is analgesic and anti-inflammatory in addition to promoting better distribution of forces, lowering pressure by weight and recovering the viscoelastic properties of synovial fluid, i.e., mechanical effects. Its prolonged effect is explained by the action of hyaluronic acid on the CD44 receptors of synoviocytes and by the reduction of activated serum T cell levels. In our experience, the addition of hilano to the lavage and injection of triamcinolone and local anesthetic led to gains in joint amplitude that were maintained over a year.

Thus, the investigators developed a study to improve the range of motion and the function of patients with mild to moderate OA of the hip through lavage with physiological saline and hydraulic distension comparing to lavage, hydraulic distension and CS injection, anesthetic and a dose of 4mL of G-F20 hilano.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hip Osteoarthritis
Intervention  ICMJE
  • Behavioral: Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine

    Patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 3mL of hylan, 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.

    Answer: WOMAC, Lequesne, VAS, EQ-5D-5L at inclusion, one week prior to surgery, 1st, 3rd, 6th and 12th months postoperatively.

    Submitted to evaluaton in the isokinetic dynamometer (Cybex 6000, Ronkokoma Lumex Inc.) where de amplitudes of movement of hip flexion, extension, abduction and adduction will be measures. Hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees/second.

    Costs will be evaluated for cost-effectiveness and cost-utility analysis.

  • Behavioral: Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine,

    Patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.

    Answer: WOMAC, Lequesne, VAS, EQ-5D-5L at inclusion, one week prior to surgery, 1st, 3rd, 6th and 12th months postoperatively.

    Submitted to evaluaton in the isokinetic dynamometer (Cybex 6000, Ronkokoma Lumex Inc.) where de amplitudes of movement of hip flexion, extension, abduction and adduction will be measures. Hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees/second.

    Costs will be evaluated for cost-effectiveness and cost-utility analysis.
Study Arms  ICMJE
  • Experimental: Experimental
    24 patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 3mL of hylan, 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.
    Intervention: Behavioral: Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine
  • Active Comparator: Control Group
    24 patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine
    Intervention: Behavioral: Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine,
Publications *
  • Pereira D, Peleteiro B, Araújo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24. Review.
  • Murphy LB, Helmick CG, Schwartz TA, Renner JB, Tudor G, Koch GG, Dragomir AD, Kalsbeek WD, Luta G, Jordan JM. One in four people may develop symptomatic hip osteoarthritis in his or her lifetime. Osteoarthritis Cartilage. 2010 Nov;18(11):1372-9. doi: 10.1016/j.joca.2010.08.005. Epub 2010 Aug 14.
  • Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013. Review.
  • Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11. Review.
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  • Murphy NJ, Eyles JP, Hunter DJ. Hip Osteoarthritis: Etiopathogenesis and Implications for Management. Adv Ther. 2016 Nov;33(11):1921-1946. Epub 2016 Sep 26. Review.
  • Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. Review.
  • Daigle ME, Weinstein AM, Katz JN, Losina E. The cost-effectiveness of total joint arthroplasty: a systematic review of published literature. Best Pract Res Clin Rheumatol. 2012 Oct;26(5):649-58. doi: 10.1016/j.berh.2012.07.013. Review.
  • Chong T, Don DW, Kao MC, Wong D, Mitra R. The value of physical examination in the diagnosis of hip osteoarthritis. J Back Musculoskelet Rehabil. 2013;26(4):397-400. doi: 10.3233/BMR-130398.
  • de Sa D, Phillips M, Catapano M, Simunovic N, Belzile EL, Karlsson J, Ayeni OR. Adhesive capsulitis of the hip: a review addressing diagnosis, treatment and outcomes. J Hip Preserv Surg. 2015 Nov 27;3(1):43-55. doi: 10.1093/jhps/hnv075. eCollection 2016 Apr. Review.
  • Ike RW, Arnold WJ, Rothschild EW, Shaw HL. Tidal irrigation versus conservative medical management in patients with osteoarthritis of the knee: a prospective randomized study. Tidal Irrigation Cooperating Group. J Rheumatol. 1992 May;19(5):772-9.
  • Chang RW, Falconer J, Stulberg SD, Arnold WJ, Manheim LM, Dyer AR. A randomized, controlled trial of arthroscopic surgery versus closed-needle joint lavage for patients with osteoarthritis of the knee. Arthritis Rheum. 1993 Mar;36(3):289-96.
  • Edelson R, Burks RT, Bloebaum RD. Short-term effects of knee washout for osteoarthritis. Am J Sports Med. 1995 May-Jun;23(3):345-9.
  • Vad VB, Sakalkale D, Warren RF. The role of capsular distention in adhesive capsulitis. Arch Phys Med Rehabil. 2003 Sep;84(9):1290-2.
  • Vad VB, Sakalkale D, Sculco TP, Wickiewicz TL. Role of hylan G-F 20 in treatment of osteoarthritis of the hip joint. Arch Phys Med Rehabil. 2003 Aug;84(8):1224-6.
  • Vad VB, Bhat AL, Sculco TP, Wickiewicz TL. Management of knee osteoarthritis: knee lavage combined with hylan versus hylan alone. Arch Phys Med Rehabil. 2003 May;84(5):634-7.
  • Richette P, Ravaud P, Conrozier T, Euller-Ziegler L, Mazières B, Maugars Y, Mulleman D, Clerson P, Chevalier X. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. Arthritis Rheum. 2009 Mar;60(3):824-30. doi: 10.1002/art.24301.
  • Ozturk C, Atamaz F, Hepguler S, Argin M, Arkun R. The safety and efficacy of intraarticular hyaluronan with/without corticosteroid in knee osteoarthritis: 1-year, single-blind, randomized study. Rheumatol Int. 2006 Feb;26(4):314-9. Epub 2005 Feb 10.
  • van Middelkoop M, Arden NK, Atchia I, Birrell F, Chao J, Rezende MU, Lambert RG, Ravaud P, Bijlsma JW, Doherty M, Dziedzic KS, Lohmander LS, McAlindon TE, Zhang W, Bierma-Zeinstra SM. The OA Trial Bank: meta-analysis of individual patient data from knee and hip osteoarthritis trials show that patients with severe pain exhibit greater benefit from intra-articular glucocorticoids. Osteoarthritis Cartilage. 2016 Jul;24(7):1143-52. doi: 10.1016/j.joca.2016.01.983. Epub 2016 Feb 2.
  • de Campos GC, Rezende MU, Pailo AF, Frucchi R, Camargo OP. Adding triamcinolone improves viscosupplementation: a randomized clinical trial. Clin Orthop Relat Res. 2013 Feb;471(2):613-20. doi: 10.1007/s11999-012-2659-y. Epub 2012 Oct 26.
  • Zhang W, Doherty M, Arden N, Bannwarth B, Bijlsma J, Gunther KP, Hauselmann HJ, Herrero-Beaumont G, Jordan K, Kaklamanis P, Leeb B, Lequesne M, Lohmander S, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Swoboda B, Varatojo R, Verbruggen G, Zimmermann-Gorska I, Dougados M; EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2005 May;64(5):669-81. Epub 2004 Oct 7. Review.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019) 		48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2020
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women diagnosed with bilateral OAH with or without comorbidities (metabolic syndrome, i.e. OA + at least two of overweight / central obesity, diabetes, dyslipidemia, hypertension)
  • Age between 60 and 75 years who are awaiting primary THR, with indication of non-surgical treatment in the contralateral limb
  • Patients without previous arthroplasties in the lower limbs.
  • Patients with no personal history of chronic inflammatory arthritis (rheumatoid arthritis, for example).
  • Patients with no personal history of cognitive, psychiatric and / or neurological disorders, whose symptoms presented at the time of evaluation are related or significantly interfere with the functions of attention, memory, logical reasoning, comprehension, in order to impair the assimilation of the given guidelines.
  • Patients able to read, understand and respond to questionnaires and perform functional tests.

Exclusion Criteria:

  • Fail to intervene and not perform the tasks determined by the professionals.
  • Patients diagnosed during the study with chronic inflammatory arthritis (rheumatoid arthritis, for example)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Livia Abreu 1126612473 murmedicina@outlook.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018690
Other Study ID Numbers  ICMJE 04019418700000068
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marcia Uchoa Rezende, University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guilherme Ocampos, MD University of São Paulo General Hospital
PRS Account University of Sao Paulo General Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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