Thumb Carpometacarpal OsteoarthritisNCT03971188

LRTI vs Internal Brace for CMC OA

A study testing Trapeziectomy with Internal Brace in people with Thumb Carpometacarpal Osteoarthritis, run by Washington University School of Medicine at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Thumb Carpometacarpal Osteoarthritis
What is being tested?: Trapeziectomy with Internal Brace
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 3 sitesUnited States
Study dates: 1 Jan 2020to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age >50
Isolated treatment of CMC arthritis
No carpal tunnel syndrome (to avoid outcome data confusion)

Who cannot join

Patients with thumb metacarpophalangeal hyperextension being addressed surgically
Patients with concurrent rheumatoid arthritis/inflammatory arthritis
Patients with history of chronic opioid use

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Washington University & Barnes-Jewish Orthopedic Center in Chesterfield
St Louis, Missouri, 63017
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Barnes-Jewish Center for Advanced Medicine - South County
St Louis, Missouri, 63129

Other trials in United States

About this study

Official title: Ligament Reconstruction Tendon Interposition Versus Internal Brace for the Surgical Treatment of Thumb Carpometacarpal Arthritis: a Prospective Randomized Trial Pilot Study

Carpometacarpal osteoarthritis (CMC OA) is a prevalent and disabling disease. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI), the most frequently performed procedure for CMC OA, requires prolonged postoperative immobilization which limits patients' abilities to perform Activities of Daily Life (ADLs) and to work. Trapezium excision and internal brace (IB) stabilization is a largely unstudied novel alternative to LRTI which has demonstrated encouraging short-term clinical outcomes and allows an expedited return to work/activity. In this feasibility and pilot grant application, our overall objective is to investigate critical questions to inform the planning of a definitive randomized controlled trial (RCT) comparing IB and LRTI for patients with CMC OA. Our central hypothesis is that a prospective RCT comparing LRTI and IB is feasible, and that IB will produce superior patient-reported outcomes to LRTI at 6 weeks and 3 months with an expedited return to work/activity. Our specific aims are to (1) Establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining the follow-up retention rate, (2) Estimate effect sizes and variability in outcomes for planning a definitive RCT, and (3) Characterize objective clinical outcomes (thumb range of motion, grip/pinch strength, radiographic outcomes, complications/need for additional surgery, and cost) and to identify differences in return to work/activity following IB and LRTI. To achieve the study's aims, the investigators will randomize 50 patients as they present to the clinics of the 7 Washington University Orthopaedic Hand surgeons to LRTI (control) or IB (experimental). Patients will follow-up at 2 weeks, 4 weeks, 3 months, and 1 year post-operatively. Primary outcomes will be feasibility (randomization rate, follow-up retention rate), and PROMIS scores at 6 weeks and 3 months. Secondary outcomes will be objective clinical outcomes and return to work/activity. Upon completion of the study's aims, the investigators expect to demonstrate that a prospective, randomized trial comparing ligament reconstruction and tendon interposition (LRTI) and internal brace (IB) is feasible, and that patients who undergo IB will have superior short-term patient-reported outcomes to those who undergo LRTI. Furthermore, the study will generate effect size and variability estimates for a definitive, subsequent randomized controlled trial (RCT). Should the objectives for this study be successful, the IB procedure may be readily incorporated into the Hand surgeon's armamentarium as a viable option for the treatment of CMC OA, and the study will provide essential data to support informed, shared decision-making among patients and their physicians.

Conditions: Thumb Carpometacarpal Osteoarthritis
Being tested: Trapeziectomy with Internal Brace

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trapeziectomy with Internal BraceProcedure or surgery
Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed.

Study groups in NCT03971188
Study group	Role	What they receive
Internal Brace	Experimental	Patients will undergo Internal Brace procedure for thumb CMC OA. Receives: Procedure: Trapeziectomy with Internal Brace
LRTI	Active comparator	Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group. Receives: Procedure: Trapeziectomy with Internal Brace

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Follow-Up Retention Rate
The investigators will establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining follow-up retention rate.
Measured: 12 months
VAS Pain Scores
Visual Analog Scale (VAS) Pain scores will be collected by a member of our team at all visits. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. Scale ranges from 0 to 10 points. For Pain, 0 indicates no pain and 10 indicates maximum pain.
Measured: 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
PROMIS Upper Extremity scores will be collected at all clinic visits on iPad as per standard protocol for all patients presenting to a Washington University Orthopaedic Surgery clinic. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. All PROMIS domain scores are normalized to a mean score of 50 and standard deviation of 10 intending to minimize floor and ceiling effects and ensure the results are readily understood and communicated. A higher score indicates better upper extremity function.
Measured: 12 months

Secondary outcomes (13)

Thumb Range of Motion: Thumb IP Joint Extension
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Measured: 12 months
Thumb Range of Motion: Thumb IP Joint Flexion
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Measured: 12 months
Thumb Range of Motion: Thumb MCP Joint Extension
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Measured: 12 months
Thumb Range of Motion: Thumb MCP Joint Flexion
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Measured: 12 months
Thumb Range of Motion: Thumb CMC Joint Palmar Abduction
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Measured: 12 months
Thumb Range of Motion: Thumb CMC Joint Palmar Adduction
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Measured: 12 months
Thumb Range of Motion: Thumb CMC Joint Radial Abduction
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Measured: 12 months
Thumb Range of Motion: Thumb CMC Joint Radial Adduction
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Measured: 12 months
Grip Strength
The investigators will record grip strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in both the operative hands. Grip strength will be measured using dynamometer and recorded in pounds (lbs).
Measured: 12 months
Pinch Strength: Lateral Pinch
The investigators will record pinch strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in the operative hand. Pinch strength will be measured using a pinch gauge and recorded in pounds (lbs). For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch."
Measured: 12 months
Pinch Strength: Three-Point Pinch
The investigators will record pinch strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in the operative hand. Pinch strength will be measured using a pinch gauge and recorded in pounds (lbs). For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch."
Measured: 12 months
Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction
Posteroanterior wrist and Roberts view C-arm XRs from pre-op, 3 months post-op, and 1 year post-op were obtained. Thumb metacarpal subsidence was calculated using the trapezial space ratio (TSR) measured on a posteroanterior wrist radiograph.
Measured: 12 months
Return to Work/Activity
The investigators will track return to work/activity by asking patients at each follow-up visit (1) IF they have returned to their work and baseline activity, and (2) if so, HOW LONG AFTER THEIR SURGERY did they return (ie, 2 weeks, 4 weeks, 6 weeks, 2 mos, 2.5 mos, 3 mos, 4 mos, 5 mos, >6 mos). Return to work and activity will be compared between the two treatment groups.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202031 Dec 2023

First posted3 Jun 2019
Study start1 Jan 2020
Primary completion30 Aug 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Thumb Carpometacarpal OsteoarthritisStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03971188
Sponsor's protocol ID: 010216
Status last verified: Mar 2025
First submitted: 20 May 2019
Last updated: 6 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
RecruitingPhase 2
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
Thumb Osteoarthritis
RecruitingObservational study
ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis
RecruitingObservational study
Study on Basal Joint Arthritis Prospective
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
RecruitingObservational study
TOUCH® CMC 1 New Enrollment US Study
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All Thumb Carpometacarpal Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ligament Reconstruction Tendon Interposition Versus Internal Brace for the Surgical Treatment of Thumb Carpometacarpal Arthritis: a Prospective Randomized Trial Pilot Study
ClinicalTrials.gov ID: NCT03971188
Acronym / sponsor ID: 010216
Conditions: Thumb Carpometacarpal Osteoarthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 30 Aug 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 3 Jun 2019 (actual)
Results: Posted 6 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Internal Brace	Experimental	Procedure: Trapeziectomy with Internal BracePatients will undergo Internal Brace procedure for thumb CMC OA.
LRTI	Active comparator	Procedure: Trapeziectomy with Internal BracePatients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age >50
Isolated treatment of CMC arthritis
No carpal tunnel syndrome (to avoid outcome data confusion)

Key exclusion criteria (3 listed)

Patients with thumb metacarpophalangeal hyperextension being addressed surgically
Patients with concurrent rheumatoid arthritis/inflammatory arthritis
Patients with history of chronic opioid use

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
Trapeziectomy with Internal BraceTrapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed.	Procedure or surgery	Internal Brace, LRTI

Primary outcome

Postoperative Follow-Up Retention Rate
Time frame: 12 months
The investigators will establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining follow-up retention rate.
VAS Pain Scores
Time frame: 12 months
Visual Analog Scale (VAS) Pain scores will be collected by a member of our team at all visits. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. Scale ranges from 0 to 10 points. For Pain, 0 indicates no pain and 10 indicates maximum pain.
Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
Time frame: 12 months
PROMIS Upper Extremity scores will be collected at all clinic visits on iPad as per standard protocol for all patients presenting to a Washington University Orthopaedic Surgery clinic. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. All PROMIS domain scores are normalized to a mean score of 50 and standard deviation of 10 intending to minimize floor and ceiling effects and ensure the results are readily understood and communicated. A higher score indicates better upper extremity function.

13 secondary outcomes

Thumb Range of Motion: Thumb IP Joint Extension
Time frame: 12 months
Thumb Range of Motion: Thumb IP Joint Flexion
Time frame: 12 months
Thumb Range of Motion: Thumb MCP Joint Extension
Time frame: 12 months
Thumb Range of Motion: Thumb MCP Joint Flexion
Time frame: 12 months
Thumb Range of Motion: Thumb CMC Joint Palmar Abduction
Time frame: 12 months
Thumb Range of Motion: Thumb CMC Joint Palmar Adduction
Time frame: 12 months
Thumb Range of Motion: Thumb CMC Joint Radial Abduction
Time frame: 12 months
Thumb Range of Motion: Thumb CMC Joint Radial Adduction
Time frame: 12 months
Grip Strength
Time frame: 12 months
Pinch Strength: Lateral Pinch
Time frame: 12 months
Pinch Strength: Three-Point Pinch
Time frame: 12 months
Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction
Time frame: 12 months
Return to Work/Activity
Time frame: 12 months

Results and safety

Results posted to the registry on 6 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Internal Brace	16	16
LRTI	15	15

Primary outcome: Postoperative Follow-Up Retention Rate

Time frame: 12 months. Count of units. Unit: thumbs

Measure	Internal Brace n = 16	LRTI n = 15
3-month follow-up: Yes	17	13
3-month follow-up: No	0	2
1-year follow-up: Yes	17	14
1-year follow-up: No	0	1

Primary outcome: VAS Pain Scores

Time frame: 12 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Internal Brace n = 16	LRTI n = 15
Pre-op	7.4 (1.3)	7.7 (1.7)
2 week	3.9 (2.3)	2.9 (2.1)
4 week	3.1 (2.3)	1.8 (1.2)
3 month	2.5 (2.3)	1.6 (1.1)
1 year	2.4 (2.5)	2.4 (2.9)

Primary outcome: Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores

Time frame: 12 months. Mean (Standard Deviation). Unit: T-score

Measure	Internal Brace n = 16	LRTI n = 15
Pre-op	32.7 (4.8)	36.0 (8.0)
2 week	27.0 (4.6)	29.6 (6.9)
4 week	31.7 (5.6)	35.6 (7.1)
3 month	38.6 (7.3)	42.7 (7.8)
1 year	41.5 (9.8)	46.7 (6.6)

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: One year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Internal Brace	1 of 17 (5.9%)	4 of 17 (23.5%)	0 of 17
LRTI	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15

Limitations and caveats (from the sponsor): First, patients randomized to LRTI and STS participated in different postoperative rehab protocols, which may be a confounding factor in interpreting outcomes. Second, it was not possible to blind surgeons or patients to the procedures and rehab protocol, introducing potential bias. Third, the size of this initial RCT was not sufficient to balance confounding variables between groups. Finally, our cohort was underpowered to detect statistically significant differences in outcome measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Thumb Carpometacarpal Osteoarthritis

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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.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Trapeziectomy with Internal Brace in people with Thumb Carpometacarpal Osteoarthritis, run by Washington University School of Medicine at 3 sites 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 3 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 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Postoperative Follow-Up Retention Rate (time frame: 12 months). 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?

On the ClinicalTrials.gov record for NCT03971188.

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 6 Apr 2025.