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

NCT03392454 | Completed

• 1 other identifier: CMCJ
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthritis; Health Related Quality of Life; Osteoarthritis

Keywords

Partial Trapeziectomy; Tendon Interposition; Trapeziectomy; Thumb Carpometacarpal Joint

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in functional performance as measured by Grip Strength

  1 week pre-operatively and 3, 6 and 12 month post-operatively

• Change in functional performance as measured by Two-Point Pinch Strength

  1 week pre-operatively and 1, 3, 6 and 12 month post-operatively

• Change in functional performance as measured by Key Pinch Strength

  1 week pre-operatively and 3, 6 and 12 month post-operatively

Study Arms (2)

T+LRTI Patients

Patients who received Trapeziectomy with Ligament Reconstruction and Tendon Interposition.

Procedure: T+LRTI

PT+TI Patients

Patients who received the Partial Trapeziectomy and Tendon Interposition

Procedure: PT+TI

Interventions

T+LRTI PROCEDURE

T+LRTI is the most commonly used procedure, it removes the entire trapezium

T+LRTI Patients

PT+TI PROCEDURE

The PT+TI is less invasive than the T+LRTI as only part of the trapezium is removed

PT+TI Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Achilles Thoma, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: January 8, 2018
• Study Start: March 1, 2012
• Primary Completion: November 30, 2015
• Study Completion: November 30, 2015
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share