Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb

Study Overview
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Brief Summary
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A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.

Detailed Description
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A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb (CMC1). The primary outcome is Patient Reported Wrist and Hand Evaluation (PRWHE) at 6 months after the randomization to treatment group. Secondary measures include PRWHE at 3 months, 1 year, 2 years and 5 years, grip strength, and global assessment of change.

Official Title
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A Multi-center, Investigator-blinded, Randomized, Parallel Group, Superiority Study to Compare the Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb

Conditions
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Thumb Osteoarthritis

Intervention / Treatment
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* Procedure: Trapeziectomy
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (NSAIDs or paracetamol, implemented for at least three months. Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain) Age > 45 years ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System) Ability to speak, understand and read in the language of the clinical site Provision of informed consent from the participant Exclusion Criteria: Patients' main complaint is due to some other problem than primary thumb basal joint (CMC1) osteoarthritis or patient will undergo any other surgery in conjunction with trapeziectomy Neurologic condition affecting the function or symptoms of the upper extremity <6 months from other surgical procedure of the upper extremities Rheumatoid arthritis or other inflammatory joint disease Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides Previous operation due tothumb basal joint (CMC1) osteoarthritis for either side >45 degrees of hyperextension in the thumb MP joint in resting position (zig zag deformity) Patient is unable to continue his/her current job due to thumb pain

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trapeziectomy<br>Trapeziectomy | Procedure: Trapeziectomy<br>* Surgical excision of trapezoideum<br>|
| Sham Comparator: Sham surgery<br>Sham surgery | Procedure: Sham<br>* Skin incision only<br>|
| Other: Non-randomized observational arm<br>Non-randomized observational arm (trapeziectomy, not blinded) | Procedure: Trapeziectomy<br>* Surgical excision of trapezoideum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported wrist and hand evaluation (PRWHE) | PROM questionnaire | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported wrist and hand evaluation (PRWHE) | PROM questionnaire | 3 months, and 1, 2, 5 years | 
| Global improvement | PROM, question (Likert scale) | 3 and 6 months, and 1, 2, and 5 years | 
| Patient accepted symptom state | PROM, question (Likert scale) | 3 and 6 months, and 1, 2, and 5 years | 
| Grip and pinch strength | Measured with dynamometer | 6 months | 
| EUROQOL EQ-5D-5L | PROM, health-related quality of life questionnaire | 3 and 6 months, and 1, 2, and 5 years |