Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

Study Overview
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Brief Summary
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A randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.

Official Title
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A Randomized Comparison Between Trapeziectomy and Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

Conditions
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Thumb Osteoarthritis

Intervention / Treatment
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* Procedure: trapeziometacarpal limited excision
* Procedure: Trapeziectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test). Pain at rest. Conservative treatment >6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection) Exclusion Criteria: Rheumatoid arthritis. Ongoing infection in the hand or wrist. - History of gout or pseudo gout. Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). Intra-articular injection in the affected joint within 6 months. Eaton Littler class 4 (STT joint involved).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trapeziectomy<br>Standard simple trapeziectomy, no pins. | Procedure: Trapeziectomy<br>* Simple trapeziectomy<br>|
| Active Comparator: trapeziometacarpal limited excision<br>Trapeziometacarpal limited excision; Narrow pseudarthrosis of the trapeziometacarpal joint. | Procedure: trapeziometacarpal limited excision<br>* Narrow pseudarthrosis CMC1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain on load NRS (numerical rating scale) | Change in rated pain on load from preoperatively to 1, 3 and 5 years postoperatively | Preoperatively, 1, 3 and 5 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nelson Thumb score | 0-100 p, higher score = less disability | Preoperatively, 1, 3 and 5 years postoperatively | 
| Change in EQ-5D | Weight mean value: 0=dead, 1= healthy | 1, 3 and 5 years postoperatively | 
| Change in DASH - Disability of the Arm, Shoulder and Hand | 0-100 p, higher score = more disability | Preoperatively, 1, 3 and 5 years postoperatively | 
| Change in PRWHE - Patient-Rated Wrist and Hand Evaluation | 0-100 p, higher score = more disability | Preoperatively, 1, 3 and 5 years postoperatively | 
| Change in HADS - Change hospital Anxiety and Depression score | 2 subscores for anxiety (0-21P) and depression (0-21p), higher score = worse | Preoperatively, 1, 3 and 5 years postoperatively | 
| Change in PCS - Pain Catastrophizing Score | 0-52, higher score = more pain catastrophizing | Preoperatively, 1, 3 and 5 years postoperatively | 
| Change in Thumb base motion | radial and palmar abduction of the first metacarpal (degrees). | Preoperatively, 1, 3 and 5 years postoperatively | 
| Change in thumb strength | Key pinch and pinch strength (Kg) | Preoperatively, 1, 3 and 5 years postoperatively |