OsteoarthritisNCT02352610
A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) With an Interference Screw for Thumb Carpometacarpal Arthritis - Pilot Study
A study testing LRTI and Biotenodesis Screw in people with Osteoarthritis, run by Andrew Trenholm at 1 site in Canada.
Trial summary
A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) with an interference screw for thumb carpometacarpal arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- LRTI and Biotenodesis Screw
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to 30 Apr 2018
- 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
- First CMC primary osteoarthritis refractory to conservative treatment
- Patient >age 18
- Able to read and understand English
- Available for 2 year follow up
Who cannot join
- Inflammatory Arthritis
- Active infection in the first CMC joint
- Concomitant neuropathy
- Previous surgical procedure on the thumb
- Active or status post CRPS
- Severe ¨Z ¨deformity that requires palmar plate advancement
- Unwilling to participate in a research project
- Contralateral first CMC joint surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H3A7
About this study
A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) with an interference screw for thumb carpometacarpal arthritis
Read the detailed description
This study will be a prospective randomized trial done in a single academic center. The patients who meet the inclusion criteria and agree to participate in the trial will be scheduled for a first CMC joint procedure. The procedure, standard LRTI or LRTI with a biotenodesis screw, will be allocated in a randomized fashion in the operating room using a sealed opaque envelope. After the surgery the patient will be placed in a spica splint for 1-2 weeks. Following suture removal, a thumb spica cast will be applied for immobilization for a total of 6 weeks of post-operative immobilisation.
The potential population for this study will include all patients with first carpometacarpal joint arthritis that have failed a conservative treatment. The primary outcome will be the thumb subsidence measured as the percentage of trapezial height, which correlates with stability. Subsidence will be measured on stress x-ray under a standard pinch load. Secondary outcomes will be function measured in 4 different ways: the range of motion compared to the contralateral side, pinch and grip strength compared to the other side, the Disabilities of the Arm Shoulder and Hand (DASH) score and the pain score on a visual analogue scale.
- Conditions
- Osteoarthritis
- Being tested
- LRTI, Biotenodesis Screw
- Keywords
- carpometacarpal joints
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LRTIProcedure or surgery
Biotenodesis ScrewDevice
| Study group | Role | What they receive |
|---|---|---|
| LRTI without a Biotenodesis Screw | Active comparator | Ligament Reconstruction Tendon Interposition without a Biotenodesis Screw Receives: Procedure: LRTI |
| LRTI with Biotenodesis Screw | Active comparator | Ligament Reconstruction Tendon Interposition with Biotenodesis Screw Receives: Procedure: LRTI; Device: Biotenodesis Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subsidence of CMC joint
Measurement of trapezial height as a percentage of pre-operative height
Measured: 6 weeks, 3 months, 6 months, 1 year, 2 years
Secondary outcomes (8)
EQ-5D Health Questionnaire Score
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
DASH questionnaire score
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Grip strength as measured by dynamometer
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Pinch strength as measured by dynamometer
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Opposition as measured by goniometer
thumb range of motion
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Radial abduction as measured by goniometer
thumb range of motion
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Palmar abduction as measured by goniometer
thumb range of motion
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Pain score on the visual analogue scale
visual analogue scale
Measured: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startMar 2015
- Primary completion22 Feb 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Trenholm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Trenholm, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352610
- Sponsor's protocol ID
- 2015-239
- Status last verified
- Jul 2018
- First submitted
- 8 Jan 2015
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) With an Interference Screw for Thumb Carpometacarpal Arthritis - Pilot Study
- ClinicalTrials.gov ID
- NCT02352610
- Acronym / sponsor ID
- 2015-239
- Conditions
- Osteoarthritis
- Keywords
- carpometacarpal joints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Andrew TrenholmUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 22 Feb 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 2 Feb 2015 (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.
A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) with an interference screw for thumb carpometacarpal arthritis
Detailed description
This study will be a prospective randomized trial done in a single academic center. The patients who meet the inclusion criteria and agree to participate in the trial will be scheduled for a first CMC joint procedure. The procedure, standard LRTI or LRTI with a biotenodesis screw, will be allocated in a randomized fashion in the operating room using a sealed opaque envelope. After the surgery the patient will be placed in a spica splint for 1-2 weeks. Following suture removal, a thumb spica cast will be applied for immobilization for a total of 6 weeks of post-operative immobilisation.
The potential population for this study will include all patients with first carpometacarpal joint arthritis that have failed a conservative treatment. The primary outcome will be the thumb subsidence measured as the percentage of trapezial height, which correlates with stability. Subsidence will be measured on stress x-ray under a standard pinch load. Secondary outcomes will be function measured in 4 different ways: the range of motion compared to the contralateral side, pinch and grip strength compared to the other side, the Disabilities of the Arm Shoulder and Hand (DASH) score and the pain score on a visual analogue scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRTI without a Biotenodesis Screw | Active comparator | Procedure: LRTILigament Reconstruction Tendon Interposition without a Biotenodesis Screw |
| LRTI with Biotenodesis Screw | Active comparator | Procedure: LRTI, Device: Biotenodesis ScrewLigament Reconstruction Tendon Interposition with Biotenodesis Screw |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First CMC primary osteoarthritis refractory to conservative treatment
- Patient >age 18
- Able to read and understand English
- Available for 2 year follow up
Key exclusion criteria (8 listed)
- Inflammatory Arthritis
- Active infection in the first CMC joint
- Concomitant neuropathy
- Previous surgical procedure on the thumb
- Active or status post CRPS
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 |
|---|---|---|
| LRTI | Procedure or surgery | LRTI with Biotenodesis Screw, LRTI without a Biotenodesis Screw |
| Biotenodesis Screw | Device | LRTI with Biotenodesis Screw |
Primary outcome
Subsidence of CMC joint
Time frame: 6 weeks, 3 months, 6 months, 1 year, 2 years
Measurement of trapezial height as a percentage of pre-operative height
8 secondary outcomes
EQ-5D Health Questionnaire Score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
DASH questionnaire score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Grip strength as measured by dynamometer
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Pinch strength as measured by dynamometer
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Opposition as measured by goniometer
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Radial abduction as measured by goniometer
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Palmar abduction as measured by goniometer
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Pain score on the visual analogue scale
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
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 17 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LRTI and Biotenodesis Screw in people with Osteoarthritis, run by Andrew Trenholm at 1 site in Canada.
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 4 inclusion and 8 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 17 Jul 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 Canada. 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?
Subsidence of CMC joint (time frame: 6 weeks, 3 months, 6 months, 1 year, 2 years). 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 17 Jul 2018.