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

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)

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.

Study Overview

• Status: Completed
• Conditions: Arthritis; Osteoarthritis; Health Related Quality of Life
• Intervention / Treatment: Procedure: T+LRTI; Procedure: PT+TI

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

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (Over the age of 18) who have been diagnosed with CMCJ OA of the thumb, Eaton stages II-IV who are english speaking with no other existing hand pathology.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Achilles Thoma, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2015

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Trapeziectomy; Partial Trapeziectomy; Tendon Interposition; Thumb Carpometacarpal Joint
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CMCJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the data will not be made to other researchers, the final results will be anonymized and hopefully published in scientific journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No