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Completed

NCT Number: NCT03392454

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T+LRTI

Procedure

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

PT+TI

Procedure

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

Primary outcomes

  1. Change in Health Related Quality of Life (HRQOL) as measured by the Short Form 36v2 (SF-36)

    Time frame: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively

    The Short-Form 36v2 [SF-36] is a Generic HRQOL questionnaire

  2. Change in Health Related Quality of Life (HRQOL) as measured by the Disabilities of the Arm, Shoulder and Hand (DASH)

    Time frame: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively

    The DASH is a condition specific questionnaire

  3. Change in HRQOL as measured by The EuroQol-5D-3L [EQ-5D]

    Time frame: 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 outcomes

  1. Change in functional performance as measured by Grip Strength

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

    Force applied by the hand, measured by a goniometer in kilograms

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

    Time frame: 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

  3. Change in functional performance as measured by Key Pinch Strength

    Time frame: 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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 8, 2018
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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