Clinical trial NCT03392454: A Case Series Comparing T+LRTI to Partial Trapeziectomy for Thumb Osteoarthritis
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Health Related Quality of Life
Osteoarthritis
Keywords: Partial Trapeziectomy
Tendon Interposition
Trapeziectomy
Thumb Carpometacarpal Joint
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Health Related Quality of Life (HRQOL) as measured by the Short Form 36v2 (SF-36)
timeFrame: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively
measure: Change in Health Related Quality of Life (HRQOL) as measured by the Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively
measure: Change in HRQOL as measured by The EuroQol-5D-3L [EQ-5D]
timeFrame: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively
Secondary outcomes:
measure: Change in functional performance as measured by Grip Strength
timeFrame: 1 week pre-operatively and 3, 6 and 12 month post-operatively
measure: Change in functional performance as measured by Two-Point Pinch Strength
timeFrame: 1 week pre-operatively and 1, 3, 6 and 12 month post-operatively
measure: Change in functional performance as measured by Key Pinch Strength
timeFrame: 1 week pre-operatively and 3, 6 and 12 month post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Achilles Thoma, MD
role: PRINCIPAL_INVESTIGATOR
References: