LRTI vs Internal Brace for CMC OA

Thumb Carpometacarpal Osteoarthritis Clinical Trial

Official title:

Ligament Reconstruction Tendon Interposition Versus Internal Brace for the Surgical Treatment of Thumb Carpometacarpal Arthritis: a Prospective Randomized Trial Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971188
• Other study ID #: 010216
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Carpometacarpal Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Barnes-Jewish Center for Advanced Medicine - South County	Saint Louis	Missouri
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Washington University & Barnes-Jewish Orthopedic Center in Chesterfield	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Randomization rate	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.	12 months
Primary	Follow-up retention rate	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.	12 months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity and Physical Function scores	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.	12 months
Secondary	Visual Analog Scale (VAS) Pain and Satisfaction scores	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.	12 months
Secondary	Thumb Range of Motion (ROM)	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.	12 months
Secondary	Grip Strength	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.	12 months
Secondary	Pinch Strength	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.	12 months
Secondary	Radiographic Subsidence of Thumb Metacarpal	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.	12 months
Secondary	Complications	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.	12 months
Secondary	Return to Work/Activity	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.	12 months