Thumb Carpometacarpal ArthritisNCT01121874
Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty
A study testing Ligament reconstruction with suture fixation system and Ligament Reconstruction with Tendon Interposition (LRTI) in people with Thumb Carpometacarpal Arthritis, run by J&M Shuler at 1 site in United States.
Trial summary
Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thumb Carpometacarpal Arthritis
- What is being tested?
- Ligament reconstruction with suture fixation system and Ligament Reconstruction with Tendon Interposition (LRTI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2010to 25 Jul 2012
- Phase
- Interventional
- 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
Who may be able to join
- Male or female patients aged >18.
- Eaton Stage III or IV CMC arthritis
- Failure to respond to conservative treatment
Who cannot join
- Previous surgical interventions on that thumb
- Upper extremity neurological dysfunction
- Inability to effectively communicate with the research staff, due to hearing impairment, cognitive impairment, or a language barrier
- Unwilling or unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial
Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.
We believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. The objective of this study is to compare functional outcome measurements among patients who receive CMC arthroplasty using a suture fixation system (investigational group) to those who receive LRTI surgery (control group). We hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.
- Conditions
- Thumb Carpometacarpal Arthritis
- Being tested
- Ligament reconstruction with suture fixation system, Ligament Reconstruction with Tendon Interposition (LRTI)
- Keywords
- CMC arthritis, thumb carpometacarpal arthritis, basal joint arthritis, thumb CMC arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligament reconstruction with suture fixation systemProcedure or surgery
Also called Arthrex Mini TightRope
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
Ligament Reconstruction with Tendon Interposition (LRTI)Procedure or surgery
commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.
Ligament reconstruction with suture fixation systemProcedure or surgery
Also called Arthrex Mini TightRope
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system, with a decreased period of immobilization from 6 weeks to 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LRTI | Active comparator | These patients will undergo ligament reconstruction with tendon interposition (LRTI) surgery. They will serve as a control group, against which to compare the investigational surgical technique. Receives: Procedure: Ligament Reconstruction with Tendon Interposition (LRTI) |
| Suture fixation system | Experimental | CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system. Receives: Procedure: Ligament reconstruction with suture fixation system |
| Suture fixation system + 2 week immobilization | Experimental | CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system, and with a decreased immobilization time from 6 to 2 weeks post-surgery. Receives: Procedure: Ligament reconstruction with suture fixation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall functionality
Functionality will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which assesses functionality of the upper extremity, and Short Form 36 (SF-36) health outcomes assessment, which quantifies global functionality (not specific to the upper extremity).
Measured: Baseline
Overall Functionality
Measured: 6 wks
Overall Functionality
Measured: 3 mos
Overall Functionality
Measured: 6 mos
Overall Functionality
Measured: 12 months
Overall Functionality
Measured: 24 months
Secondary outcomes (5)
Analog pain scale
Pain will be assessed using the visual analog pain scale, which asks the patient to rate their pain on a scale from 1 to 10.
Measured: Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Strength measures
Strength will be assessed via key and tip pinch strength and grip strength, using a dynamometer
Measured: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Range of motion
Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm).
Measured: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Operative time
Operative time in minutes
Measured: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Scaphometacarpal distance
Distance between the distal pole of the scaphoid and the proximal aticular surface of the metacarpal. Taken in stressed and relaxed views
Measured: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study start12 Apr 2010
- Primary completion21 May 2012
- Study completion25 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb Carpometacarpal ArthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- J&M Shuler
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Michael Shuler, J&M Shuler
- Investigators
- Michael Shuler, MD, Principal investigator, Athens Orthopedic Clinic, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121874
- Sponsor's protocol ID
- CMC-101
- Status last verified
- Aug 2018
- First submitted
- 9 Apr 2010
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01121874
- Acronym / sponsor ID
- CMC-101
- Conditions
- Thumb Carpometacarpal Arthritis
- Keywords
- CMC arthritis, thumb carpometacarpal arthritis, basal joint arthritis, thumb CMC arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- J&M ShulerIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2010 (actual)
- Primary completion
- 21 May 2012 (actual)
- Study completion
- 25 Jul 2012 (actual)
- First posted
- 12 May 2010 (estimated)
- 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.
Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.
We believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. The objective of this study is to compare functional outcome measurements among patients who receive CMC arthroplasty using a suture fixation system (investigational group) to those who receive LRTI surgery (control group). We hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LRTI | Active comparator | Procedure: Ligament Reconstruction with Tendon Interposition (LRTI)These patients will undergo ligament reconstruction with tendon interposition (LRTI) surgery. They will serve as a control group, against which to compare the investigational surgical technique. |
| Suture fixation system | Experimental | Procedure: Ligament reconstruction with suture fixation systemCMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system. |
| Suture fixation system + 2 week immobilization | Experimental | Procedure: Ligament reconstruction with suture fixation systemCMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system, and with a decreased immobilization time from 6 to 2 weeks post-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged >18.
- Eaton Stage III or IV CMC arthritis
- Failure to respond to conservative treatment
Key exclusion criteria (4 listed)
- Previous surgical interventions on that thumb
- Upper extremity neurological dysfunction
- Inability to effectively communicate with the research staff, due to hearing impairment, cognitive impairment, or a language barrier
- Unwilling or unable to provide written informed consent
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 |
|---|---|---|
| Ligament reconstruction with suture fixation systemAlso: Arthrex Mini TightRopeCMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system | Procedure or surgery | Suture fixation system |
| Ligament Reconstruction with Tendon Interposition (LRTI)commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist. | Procedure or surgery | LRTI |
| Ligament reconstruction with suture fixation systemAlso: Arthrex Mini TightRopeCMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system, with a decreased period of immobilization from 6 weeks to 2 weeks. | Procedure or surgery | Suture fixation system + 2 week immobilization |
Primary outcome
Overall functionality
Time frame: Baseline
Functionality will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which assesses functionality of the upper extremity, and Short Form 36 (SF-36) health outcomes assessment, which quantifies global functionality (not specific to the upper extremity).
Overall Functionality
Time frame: 6 wks
Overall Functionality
Time frame: 3 mos
Overall Functionality
Time frame: 6 mos
Overall Functionality
Time frame: 12 months
Overall Functionality
Time frame: 24 months
5 secondary outcomes
Analog pain scale
Time frame: Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Strength measures
Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Range of motion
Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Operative time
Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Scaphometacarpal distance
Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
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 15 Aug 2018.
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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.
Michael Shuler, MD principal investigator
Athens Orthopedic Clinic, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligament reconstruction with suture fixation system and Ligament Reconstruction with Tendon Interposition (LRTI) in people with Thumb Carpometacarpal Arthritis, run by J&M Shuler at 1 site in United States.
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 3 inclusion and 4 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Overall functionality (time frame: Baseline). The study lists 6 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 15 Aug 2018.