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出境医 / 临床实验 / LRTI vs Internal Brace for CMC OA
LRTI vs Internal Brace for CMC OA
Study Description
Brief Summary:
Carpometacarpal osteoarthritis (CMC OA) is a prevalent and disabling disease. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI), the most frequently performed procedure for CMC OA, requires prolonged postoperative immobilization which limits patients' abilities to perform Activities of Daily Life (ADLs) and to work. Trapezium excision and internal brace (IB) stabilization is a largely unstudied novel alternative to LRTI which has demonstrated encouraging short-term clinical outcomes and allows an expedited return to work/activity. In this feasibility and pilot grant application, our overall objective is to investigate critical questions to inform the planning of a definitive randomized controlled trial (RCT) comparing IB and LRTI for patients with CMC OA. Our central hypothesis is that a prospective RCT comparing LRTI and IB is feasible, and that IB will produce superior patient-reported outcomes to LRTI at 6 weeks and 3 months with an expedited return to work/activity. Our specific aims are to (1) Establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining the follow-up retention rate, (2) Estimate effect sizes and variability in outcomes for planning a definitive RCT, and (3) Characterize objective clinical outcomes (thumb range of motion, grip/pinch strength, radiographic outcomes, complications/need for additional surgery, and cost) and to identify differences in return to work/activity following IB and LRTI. To achieve the study's aims, the investigators will randomize 50 patients as they present to the clinics of the 7 Washington University Orthopaedic Hand surgeons to LRTI (control) or IB (experimental). Patients will follow-up at 2 weeks, 4 weeks, 3 months, and 1 year post-operatively. Primary outcomes will be feasibility (randomization rate, follow-up retention rate), and PROMIS scores at 6 weeks and 3 months. Secondary outcomes will be objective clinical outcomes and return to work/activity. Upon completion of the study's aims, the investigators expect to demonstrate that a prospective, randomized trial comparing ligament reconstruction and tendon interposition (LRTI) and internal brace (IB) is feasible, and that patients who undergo IB will have superior short-term patient-reported outcomes to those who undergo LRTI. Furthermore, the study will generate effect size and variability estimates for a definitive, subsequent randomized controlled trial (RCT). Should the objectives for this study be successful, the IB procedure may be readily incorporated into the Hand surgeon's armamentarium as a viable option for the treatment of CMC OA, and the study will provide essential data to support informed, shared decision-making among patients and their physicians.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Thumb Carpometacarpal Osteoarthritis | Procedure: Trapeziectomy with Internal Brace | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | LRTI vs Internal Brace for CMC OA: A Prospective Randomized Trial |
| Actual Study Start Date : | January 1, 2020 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Experimental: Internal Brace
Patients will undergo Internal Brace procedure for thumb CMC OA.
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Procedure: Trapeziectomy with Internal Brace
Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed.
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Active Comparator: LRTI
Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group.
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Procedure: Trapeziectomy with Internal Brace
Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed.
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Outcome Measures
Primary Outcome Measures :
- Randomization rate [ Time Frame: 12 months ]The investigators will establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining follow-up retention rate.
- Follow-up retention rate [ Time Frame: 12 months ]The investigators will establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining follow-up retention rate.
Secondary Outcome Measures :
- Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity and Physical Function scores [ Time Frame: 12 months ]PROMIS Physical Function and Upper Extremity scores will be collected at all clinic visits on iPad as per standard protocol for all patients presenting to a Washington University Orthopaedic Surgery clinic. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. All PROMIS domain scores are normalized to a mean score of 50 and standard deviation of 10 intending to minimize floor and ceiling effects and ensure the results are readily understood and communicated. Higher scores on all PROMIS Computer Adaptive Tests (CATs) indicate more of the domain measured such that higher scores on Physical Function are associated with greater function. The Upper Extremity and Physical Function scores will be reported independently, and will not be summed.
- Visual Analog Scale (VAS) Pain and Satisfaction scores [ Time Frame: 12 months ]Visual Analog Scale Pain and Satisfaction scores will be collected by a member of our team at all visits. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. Scale ranges from 0 to 10 points. For Pain, 0 indicates no pain and 10 indicates maximum pain. For Satisfaction, 0 indicates most unsatisfied and 10 indicates most satisfied.
- Thumb Range of Motion (ROM) [ Time Frame: 12 months ]Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
- Grip Strength [ Time Frame: 12 months ]The investigators will record pinch and grip strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in both the operative and contralateral hands. Pinch strength will be measured using a pinch gauge and recorded in kilograms. For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch". Grip strength will be measured using dynamometer and recorded in kilograms.
- Pinch Strength [ Time Frame: 12 months ]The investigators will record pinch and grip strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in both the operative and contralateral hands. Pinch strength will be measured using a pinch gauge and recorded in kilograms. For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch". Grip strength will be measured using dynamometer and recorded in kilograms.
- Radiographic Subsidence of Thumb Metacarpal [ Time Frame: 12 months ]Posteroanterior wrist and Roberts view C-arm XRs from pre-op, 3 months post-op, and 1 year post-op will be obtained. Subsidence of the thumb metacarpal will be measured in millimeters and compared between the two groups.
- Complications [ Time Frame: 12 months ]Complications will recorded at all time points post-op and will be tracked as binary (yes/no). There will be 3 levels of severity- mild, moderate, and severe. Mild- minor clinical significance (i.e., scar tenderness or sensory disturbances). Moderate- clinically relevant with delay in patient recovery, but not severe enough to necessitate revision surgery and resolved 12 months post-op (i.e., mild Complex Regional Pain Syndrome type I, tendinitis, neuromas treated with steroid injections). Severe- result in revision surgery, pain at rest, or impaired hand function at 12 month exam (i.e., severe Complex Regional Pain Syndrome type I or tendinitis and neuromas that did not improve with corticosteroid injections and required surgery). Complications will be compared between the two treatment groups.
- Return to Work/Activity [ Time Frame: 12 months ]The investigators will track return to work/activity by asking patients at each follow-up visit (1) IF they have returned to their work and baseline activity, and (2) if so, HOW LONG AFTER THEIR SURGERY did they return (ie, 2 weeks, 4 weeks, 6 weeks, 2 mos, 2.5 mos, 3 mos, 4 mos, 5 mos, >6 mos). Return to work and activity will be compared between the two treatment groups.
Eligibility Criteria
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age >50
- Isolated treatment of CMC arthritis
- No carpal tunnel syndrome (to avoid outcome data confusion)
Exclusion Criteria:
- Patients with thumb metacarpophalangeal hyperextension being addressed surgically
- Patients with concurrent rheumatoid arthritis/inflammatory arthritis
- Patients with history of chronic opioid use
Contacts and Locations
Contacts
| Contact: John CF Clohisy, M.D. | 314-482-4149 | clohisyjc@wustl.edu | |
| Contact: Amanda Braun, M.A. | 314-362-3768 | ahaas22@wustl.edu |
Locations
| United States, Missouri | |
| Washington University & Barnes-Jewish Orthopedic Center in Chesterfield | Recruiting |
| Saint Louis, Missouri, United States, 63017 | |
| Contact: John C Clohisy 314-482-4149 ext 3144824149 clohisyjc@wustl.edu | |
| Barnes-Jewish Hospital | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: John C Clohisy 314-482-4149 clohisyjc@wustl.edu | |
| Barnes-Jewish Center for Advanced Medicine - South County | Recruiting |
| Saint Louis, Missouri, United States, 63129 | |
| Contact: John C Clohisy 314-482-4149 ext 3144824149 clohisyjc@wustl.edu | |
Sponsors and Collaborators
Washington University School of Medicine
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 20, 2019 | ||||||||
| First Posted Date ICMJE | June 3, 2019 | ||||||||
| Last Update Posted Date | April 15, 2021 | ||||||||
| Actual Study Start Date ICMJE | January 1, 2020 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | LRTI vs Internal Brace for CMC OA | ||||||||
| Official Title ICMJE | LRTI vs Internal Brace for CMC OA: A Prospective Randomized Trial | ||||||||
| Brief Summary | Carpometacarpal osteoarthritis (CMC OA) is a prevalent and disabling disease. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI), the most frequently performed procedure for CMC OA, requires prolonged postoperative immobilization which limits patients' abilities to perform Activities of Daily Life (ADLs) and to work. Trapezium excision and internal brace (IB) stabilization is a largely unstudied novel alternative to LRTI which has demonstrated encouraging short-term clinical outcomes and allows an expedited return to work/activity. In this feasibility and pilot grant application, our overall objective is to investigate critical questions to inform the planning of a definitive randomized controlled trial (RCT) comparing IB and LRTI for patients with CMC OA. Our central hypothesis is that a prospective RCT comparing LRTI and IB is feasible, and that IB will produce superior patient-reported outcomes to LRTI at 6 weeks and 3 months with an expedited return to work/activity. Our specific aims are to (1) Establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining the follow-up retention rate, (2) Estimate effect sizes and variability in outcomes for planning a definitive RCT, and (3) Characterize objective clinical outcomes (thumb range of motion, grip/pinch strength, radiographic outcomes, complications/need for additional surgery, and cost) and to identify differences in return to work/activity following IB and LRTI. To achieve the study's aims, the investigators will randomize 50 patients as they present to the clinics of the 7 Washington University Orthopaedic Hand surgeons to LRTI (control) or IB (experimental). Patients will follow-up at 2 weeks, 4 weeks, 3 months, and 1 year post-operatively. Primary outcomes will be feasibility (randomization rate, follow-up retention rate), and PROMIS scores at 6 weeks and 3 months. Secondary outcomes will be objective clinical outcomes and return to work/activity. Upon completion of the study's aims, the investigators expect to demonstrate that a prospective, randomized trial comparing ligament reconstruction and tendon interposition (LRTI) and internal brace (IB) is feasible, and that patients who undergo IB will have superior short-term patient-reported outcomes to those who undergo LRTI. Furthermore, the study will generate effect size and variability estimates for a definitive, subsequent randomized controlled trial (RCT). Should the objectives for this study be successful, the IB procedure may be readily incorporated into the Hand surgeon's armamentarium as a viable option for the treatment of CMC OA, and the study will provide essential data to support informed, shared decision-making among patients and their physicians. | ||||||||
| Detailed Description | Not Provided | ||||||||
| 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 |
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| Condition ICMJE | Thumb Carpometacarpal Osteoarthritis | ||||||||
| Intervention ICMJE | Procedure: Trapeziectomy with Internal Brace
Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
50 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03971188 | ||||||||
| Other Study ID Numbers ICMJE | 010216 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Washington University School of Medicine | ||||||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Washington University School of Medicine | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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