ArthritisNCT03392454
A Case Series Comparing T+LRTI to Partial Trapeziectomy for Thumb Osteoarthritis
An observational study of Arthritis and Health Related Quality of Life, run by McMaster University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Health Related Quality of Life, Osteoarthritis
- What is being tested?
- T+LRTI and PT+TI
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2012to 30 Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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)
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.
Read the 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
- Conditions
- Arthritis, Health Related Quality of Life, Osteoarthritis
- Being tested
- T+LRTI, PT+TI
- Keywords
- Partial Trapeziectomy, Tendon Interposition, Trapeziectomy, Thumb Carpometacarpal Joint
- Medical subject headings
- Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T+LRTIProcedure or surgery
T+LRTI is the most commonly used procedure, it removes the entire trapezium
PT+TIProcedure or surgery
The PT+TI is less invasive than the T+LRTI as only part of the trapezium is removed
| Study group | Role | What they receive |
|---|---|---|
| T+LRTI Patients | Patients who received Trapeziectomy with Ligament Reconstruction and Tendon Interposition. Receives: Procedure: T+LRTI | |
| PT+TI Patients | Patients who received the Partial Trapeziectomy and Tendon Interposition Receives: Procedure: PT+TI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Force applied by the hand, measured by a goniometer in kilograms
Measured: 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
Measured: 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
Measured: 1 week pre-operatively and 3, 6 and 12 month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Mar 2012
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Achilles Thoma, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392454
- Sponsor's protocol ID
- CMCJ
- Status last verified
- Mar 2024
- First submitted
- 6 Dec 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data will not be made to other researchers, the final results will be anonymized and hopefully published in scientific journals
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03392454
- Acronym / sponsor ID
- CMCJ
- Conditions
- Arthritis, Health Related Quality of Life, Osteoarthritis
- Keywords
- Partial Trapeziectomy, Tendon Interposition, Trapeziectomy, Thumb Carpometacarpal Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T+LRTI Patients | – | Procedure: T+LRTIPatients who received Trapeziectomy with Ligament Reconstruction and Tendon Interposition. |
| PT+TI Patients | – | Procedure: PT+TIPatients who received the Partial Trapeziectomy and Tendon Interposition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T+LRTIT+LRTI is the most commonly used procedure, it removes the entire trapezium | Procedure or surgery | T+LRTI Patients |
| PT+TIThe PT+TI is less invasive than the T+LRTI as only part of the trapezium is removed | Procedure or surgery | PT+TI Patients |
Primary outcome
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
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
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
3 secondary outcomes
Change in functional performance as measured by Grip Strength
Time frame: 1 week pre-operatively and 3, 6 and 12 month post-operatively
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
Change in functional performance as measured by Key Pinch Strength
Time frame: 1 week pre-operatively and 3, 6 and 12 month post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No. the data will not be made to other researchers, the final results will be anonymized and hopefully published in scientific journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achilles Thoma, MD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Health Related Quality of Life, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.