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出境医 / 临床实验 / a Single Intraarticular Injection of PRP for Early Knee OA

a Single Intraarticular Injection of PRP for Early Knee OA

Study Description
Brief Summary:
This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: PRP Not Applicable

Detailed Description:

Platelet-rich plasma (PRP) has been reported to be effective for the treatment of knee osteoarthritis (OA). This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.

In a prospective trial with 6-month follow-up, patients with early knee OA were recruited and received a single intraarticular PRP injection. Several outcomes were measured.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Clinical trials with a single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of a Single Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Early Knee Osteoarthritis
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017
Arms and Interventions
Arm Intervention/treatment
Experimental: PRP injection
The patients received a single 3-ml injection of PRP.
 Other: PRP
The patients received a single 3-ml injection of PRP. Approximately 10-mL of venous blood was drawn from each patient and centrifuged using an Arthrex autologous conditioned plasma (ACP) kit (a low-leukocyte ACP system), spun at a speed of 1500 rpm for 5 minutes. The platelet concentration obtained was approximately 2-3 times greater than the baseline platelet concentration.
Outcome Measures
Primary Outcome Measures :
  1. VAS pain [ Time Frame: 6 months ]
    The primary outcome was the change from baseline in the VAS pain score at 6 months. The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0=no pain to 100=worst possible pain)


Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 6 months ]
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale) is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function [17]. The patient answers the questions and then receives a cumulative score in each of the 3 areas (pain, 0-20; stiffness, 0-8; physical function, 0-68). Total score is 96 and higher scores indicate worse outcomes.

  2. Lequesne index [ Time Frame: 6 months ]
    Lequesne index is used to assess severity of knee symptoms during the last week .It is validated and includes the measurement of pain (5 items), walking distance (2 items), and activities of daily living (4 items). Maximal score is 24 and higher scores represent worse function.

  3. Single-leg stance test (SLS) [ Time Frame: 6 months ]
    Single-leg stance test (SLS) is done by raising one foot up without touching it to the supported lower extremity with target knee and maintain balance for as long as possible. Each participant performed 3 trials, and the best result of the 3 trials was recorded

  4. Patients satisfaction [ Time Frame: 6 months ]
    Patients were asked to rate their treatment satisfaction compared to the preinjection condition, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied)

  5. safety assessment [ Time Frame: during the study, for 6 months ]
    The safety assessment was based on adverse events reported by the patients during the study and physical findings by the evaluator at each follow-up. The occurrence of adverse events was recorded, including duration, action taken and outcome.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 20-70 years
  • symptomatic knee OA with pain for at least 6 months despite conservative treatment such as analgesics, NSAIDs and/or physical therapy
  • average knee pain of at least 30 mm on a 100-mm visual analog (VAS) scale
  • grade 1 or 2 knee OA according to the Kellgren-Lawrence grading system based on -radiographs taken within the previous 6 months
  • Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

Exclusion Criteria:

  • previous orthopedic surgery on the spine or lower limbs
  • disabling OA of either hip or foot
  • knee instability or marked valgus/varus deformity
  • history of severe knee trauma; intraarticular injections into the knee in the past 6 months
  • infections or skin diseases around the target knee
  • women ascertained or suspected pregnancy or lactating
  • presence of malignancy, hematological disease, collagen vascular diseases, or autoimmune diseases;
  • therapy with anticoagulants or anti-aggregating agent
  • serious medical conditions that would interfere with the assessments during the study.
Contacts and Locations

Locations
Layout table for location information
Taiwan
Department of Physical Medicine and Rehabilitation, Veterans General Hospital,
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Layout table for investigator information
Principal Investigator: Shu Fen Sun, MD Kaohsiung Veterans General Hospital, Taiwan
Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019) 		VAS pain [ Time Frame: 6 months ]
The primary outcome was the change from baseline in the VAS pain score at 6 months. The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0=no pain to 100=worst possible pain)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 6 months ]
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale) is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function [17]. The patient answers the questions and then receives a cumulative score in each of the 3 areas (pain, 0-20; stiffness, 0-8; physical function, 0-68). Total score is 96 and higher scores indicate worse outcomes.
  • Lequesne index [ Time Frame: 6 months ]
    Lequesne index is used to assess severity of knee symptoms during the last week .It is validated and includes the measurement of pain (5 items), walking distance (2 items), and activities of daily living (4 items). Maximal score is 24 and higher scores represent worse function.
  • Single-leg stance test (SLS) [ Time Frame: 6 months ]
    Single-leg stance test (SLS) is done by raising one foot up without touching it to the supported lower extremity with target knee and maintain balance for as long as possible. Each participant performed 3 trials, and the best result of the 3 trials was recorded
  • Patients satisfaction [ Time Frame: 6 months ]
    Patients were asked to rate their treatment satisfaction compared to the preinjection condition, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied)
  • safety assessment [ Time Frame: during the study, for 6 months ]
    The safety assessment was based on adverse events reported by the patients during the study and physical findings by the evaluator at each follow-up. The occurrence of adverse events was recorded, including duration, action taken and outcome.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE a Single Intraarticular Injection of PRP for Early Knee OA
Official Title  ICMJE Efficacy of a Single Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Early Knee Osteoarthritis
Brief Summary This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.
Detailed Description

Platelet-rich plasma (PRP) has been reported to be effective for the treatment of knee osteoarthritis (OA). This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.

In a prospective trial with 6-month follow-up, patients with early knee OA were recruited and received a single intraarticular PRP injection. Several outcomes were measured.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Clinical trials with a single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Other: PRP
The patients received a single 3-ml injection of PRP. Approximately 10-mL of venous blood was drawn from each patient and centrifuged using an Arthrex autologous conditioned plasma (ACP) kit (a low-leukocyte ACP system), spun at a speed of 1500 rpm for 5 minutes. The platelet concentration obtained was approximately 2-3 times greater than the baseline platelet concentration.
Study Arms  ICMJE Experimental: PRP injection
The patients received a single 3-ml injection of PRP.
Intervention: Other: PRP
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2019) 		41
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aged 20-70 years
  • symptomatic knee OA with pain for at least 6 months despite conservative treatment such as analgesics, NSAIDs and/or physical therapy
  • average knee pain of at least 30 mm on a 100-mm visual analog (VAS) scale
  • grade 1 or 2 knee OA according to the Kellgren-Lawrence grading system based on -radiographs taken within the previous 6 months
  • Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

Exclusion Criteria:

  • previous orthopedic surgery on the spine or lower limbs
  • disabling OA of either hip or foot
  • knee instability or marked valgus/varus deformity
  • history of severe knee trauma; intraarticular injections into the knee in the past 6 months
  • infections or skin diseases around the target knee
  • women ascertained or suspected pregnancy or lactating
  • presence of malignancy, hematological disease, collagen vascular diseases, or autoimmune diseases;
  • therapy with anticoagulants or anti-aggregating agent
  • serious medical conditions that would interfere with the assessments during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027738
Other Study ID Numbers  ICMJE VGHKS106-131
Has Data Monitoring Committee No
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 Not Provided
Responsible Party Shu-Fen Sun, Kaohsiung Veterans General Hospital.
Study Sponsor  ICMJE Kaohsiung Veterans General Hospital.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shu Fen Sun, MD Kaohsiung Veterans General Hospital, Taiwan
PRS Account Kaohsiung Veterans 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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