A Prospective, Randomized Trial of Mobilization Protocols Following Ligament Reconstruction and Tendon Interposition.
Douglas T Hutchinson, Stephanie Sueoka, Angela A Wang...
https://pubmed.ncbi.nlm.nih.gov/30063589/Actively Recruiting
Led by Julie Nuelle · Updated on 2026-06-05
180
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are evaluating how formal occupational therapy compares with home exercise programs for patients recovering from trapeziectomy and suture suspensionplasty surgery for thumb carpometacarpal CMC arthritis. The study aims to determine if in-clinic therapy offers better outcomes than at-home exercises and to analyze the associated costs of each approach, especially considering challenges faced by patients living in rural areas. This is a prospective, randomized, controlled trial designed to provide clear evidence regarding post-operative therapy options. Participants will be randomly assigned to one of two groups one receives weekly in-clinic occupational therapy sessions lasting 30 to 60 minutes for six weeks, while the other group is given instructions and a booklet for a home exercise program to perform daily at home with occasional physician check-ins during routine follow-ups. The study will compare these two treatment approaches in terms of their effect on recovery and cost differences, including preoperative, intra-operative, and postoperative expenses. Throughout the study, participants progress will be assessed at multiple time points up to one year after surgery using measures such as the Kapandji Score, radial abduction range, key pinch strength, grip strength, and PROMIS questionnaires on upper extremity function and overall health. The study includes scheduled evaluations at 2 weeks, 6 weeks, 12 weeks, 6 months, and 1 year to monitor recovery and function. This comprehensive follow-up ensures detailed tracking of participant outcomes and therapy effectiveness.
CONDITIONS
Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?
B
Bryce T Fletcher, BS, CCRP
V
Vicki Jones, MEd, CCRP
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Julie Nuelle
Lead Sponsor
Arthrex, Inc.
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | In-Clinic Occupational Therapy | Booklet-Guided Home Exercise | Home-Based Video-Assisted Hand Therapy |
|---|---|---|---|
| What is it? | Weekly in-person occupational therapy with a certified hand therapist for 6 weeks after thumb CMC arthroplasty. | A structured booklet guides independent home exercises, including range of motion and strengthening, following surgery. | A home-based program using video support for hand therapy, enabling remote participation after thumb CMC arthroplasty. |
| Role in the trial | Participants are randomized to receive formal occupational therapy with scheduled sessions led by a hand therapist. | Participants are randomized to perform home exercises independently by following a booklet after surgery. | Not a randomized trial arm; serves as a current-care option based on published evidence. |
| Primary use | To support recovery of thumb strength, motion, and function through guided therapy after surgery. | To enable self-directed improvement in thumb function and strength after surgery. | To provide therapist-guided rehabilitation remotely, focusing on outcomes similar to in-person care. |
| How it is given or performed | Patients attend weekly scheduled sessions with a hand therapist over 6 weeks. | Patients perform exercises independently at home based on booklet instructions. | Therapist guidance is delivered through video sessions, allowing exercises and feedback from home. |
| Evidence status | Formal occupational therapy is supported by randomized trial evidence and clinical experience for post-operative recovery. | Randomized studies indicate that booklet-guided home exercise may achieve similar recovery outcomes as formal therapy in some patients. | Recent evidence shows that home-based video-assisted therapy is non-inferior to in-person therapy in functional recovery after thumb CMC arthroplasty. |
| Important limitations | Regular attendance for in-person therapy can be burdensome for patients living far from clinics or with mobility challenges. | Patients may lack motivation or proper technique without formal supervision, and adherence to exercises can vary. | Access to video devices and reliable internet connectivity may limit use for some patients; results depend on patient engagement with the technology. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo trapeziectomy and suture suspensionplasty surgery for thumb carpometacarpal arthritis.
1 visit (in-person)
Duration - 6 weeks
Participants receive either weekly in-clinic occupational therapy or complete a home exercise program following surgery.
1 to 2 weekly visits depending on assigned therapy
Duration - Up to 1 year
Participants attend follow-up visits to assess recovery and outcomes after surgery and therapy.
Visits at 2 weeks, 6 weeks, 12 weeks, 6 months, and 1 year
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/38608035/Julie Nuelle
Lead Sponsor
Arthrex, Inc.
Collaborating Sponsor