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

Completed

• Conditions: Arthritis; Health Related Quality of Life; Osteoarthritis
• Interventions: Procedure: PT+TI; Procedure: T+LRTI

• Registration Number: NCT03392454
• Lead Sponsor: McMaster University

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-03-01
• Primary Completion: 2015-11-30
• Study Completion: 2015-11-30
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PT+TI Patients	PT+TI	Patients who received the Partial Trapeziectomy and Tendon Interposition
T+LRTI Patients	T+LRTI	Patients who received Trapeziectomy with Ligament Reconstruction and Tendon Interposition.

Primary Outcome Measures

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

Secondary Outcome Measures

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