A Case Series Comparing T+LRTI to Partial Trapeziectomy for Thumb Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study was to measure the differences in Health Related Quality of Life (HRQOL) and functional measurements between two groups of patients with Carpometacarpal Osteoarthritis of the thumb.

Detailed Description
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Two patient groups, who have been diagnosed with Carpometacarpal Osteoarthritis of the thumb were compared to measure the Health Related Quality of life (HRQOL) and functional outcomes following two different surgical procedures. The first procedure is currently the most used procedure is North America, Trapeziectomy with Ligament Reconstruction and Tendon Interposition (T+LRTI); this procedure is compared to Partial Trapeziectomy and Tendon Interposition (PT+TI). HRQOL is measured using three questionnaires: one generic, one condition specific and one to measure utility (costs). Patients received their procedures from the respective surgeons and then came in for regular follow up at 1, 3, 6 and 12 months. At these follow up visits the questionnaires and functional measurements (including grip, key pinch and tip pinch strength), were completed

Official Title
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Measuring the Quality of Life in Patients Receiving a Partial Trapeziectomy (PT) Using a Minimalist Approach Versus a Complete Trapeziectomy With Ligament Reconstruction and Tendon Interposition (T+LRTI)

Conditions
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Arthritis, Health Related Quality of Life, Osteoarthritis

Intervention / Treatment
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* Procedure: T+LRTI
* Procedure: PT+TI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of advanced stage (Eaton stages II-IV) Carpometacarpal joint (CMCJ) osteoarthritis (OA of the thumb Willingness to undergo surgery for CMCJ OA; Over the age of 18; Able to provide informed consent; and Ability to read and comprehend English to complete the HRQOL questionnaires Exclusion Criteria: 1) Diagnosis of Eaton stage I CMCJ OA of the thumb [17]; 2) Under the age of 18; 3) Presence of any concomitant hand pathology (including rheumatoid arthritis, neuropathy and traumatic arthritis); and 4) Previous surgery on the same hand or currently under consideration for other unrelated hand surgery

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T+LRTI Patients<br>Patients who received Trapeziectomy with Ligament Reconstruction and Tendon Interposition. | Procedure: T+LRTI<br>* T+LRTI is the most commonly used procedure, it removes the entire trapezium<br>|
| PT+TI Patients<br>Patients who received the Partial Trapeziectomy and Tendon Interposition | Procedure: PT+TI<br>* The PT+TI is less invasive than the T+LRTI as only part of the trapezium is removed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Related Quality of Life (HRQOL) as measured by the Short Form 36v2 (SF-36) | The Short-Form 36v2 [SF-36] is a Generic HRQOL questionnaire | 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively | 
| Change in Health Related Quality of Life (HRQOL) as measured by the Disabilities of the Arm, Shoulder and Hand (DASH) | The DASH is a condition specific questionnaire | 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively | 
| Change in HRQOL as measured by The EuroQol-5D-3L [EQ-5D] | The EQ-5D is a questionnaire that allows utility to be calculated | 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional performance as measured by Grip Strength | Force applied by the hand, measured by a goniometer in kilograms | 1 week pre-operatively and 3, 6 and 12 month post-operatively | 
| Change in functional performance as measured by Two-Point Pinch Strength | Force applied by the tip of the thumb and the tip of the index finger, measured by a goniometer in kilograms | 1 week pre-operatively and 1, 3, 6 and 12 month post-operatively | 
| Change in functional performance as measured by Key Pinch Strength | Force applied by the pad of the thumb and lateral surface of the index finger, measured by a goniometer in kilograms | 1 week pre-operatively and 3, 6 and 12 month post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial Trapeziectomy, Tendon Interposition, Trapeziectomy, Thumb Carpometacarpal Joint