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

Osteoarthritis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392454
• Other study ID #: CMCJ
• Status: Completed
• Start date: March 1, 2012
• Est. completion date: November 30, 2015

Study information

• Verified date: March 2024
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2015
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Health Related Quality of Life
• Osteoarthritis

Intervention

Procedure:
• T+LRTI
T+LRTI is the most commonly used procedure, it removes the entire trapezium
• PT+TI
The PT+TI is less invasive than the T+LRTI as only part of the trapezium is removed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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