Basal Joint ArthritisNCT03722537
Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
A study testing Osteochondral Allograft and Ligament Reconstruction Tendon Interposition in people with Basal Joint Arthritis, run by Columbia University at 1 site in United States.
Trial summary
This is a study comparing the current standard of care surgical treatment to a newer surgical procedure involving the implantation of osteochondral allograft at the base of the thumb. Patients will be followed at 1, 3, 6 months and 1 year post-operatively. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Basal Joint Arthritis
- What is being tested?
- Osteochondral Allograft and Ligament Reconstruction Tendon Interposition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2019to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Indicated for operative management of basal joint arthritis
Who cannot join
- Pregnant women/fetuses/neonates, prisoners
- Previously operated on for treatment of basal joint arthritis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Melvin P Rossenwasser, MD
About this study
This is a study comparing the current standard of care surgical treatment to a newer surgical procedure involving the implantation of osteochondral allograft at the base of the thumb. Patients will be followed at 1, 3, 6 months and 1 year post-operatively.
Read the detailed description
Basal joint arthritis of the thumb is a common condition associated with considerable morbidity. Many non-operative and operative treatments have been described, but few multicenter prospective evidence based trials exist comparing standard treatments. This continuing search for consensus and improvement of best clinical practice has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Operative treatments range from osteotomy, partial or complete trapeziectomy with or without reconstruction of the ligaments, tendon interposition to arthrodesis, however the functional outcome varies. Allograft has been previously described in joint replacement / prosthetic implantation surgery in other areas of the body, however not in the thumb. The purpose of this study is to investigate using osteochondral allograft in the surgical intervention phase of treatment for patients with basal joint arthritis.
- Conditions
- Basal Joint Arthritis
- Being tested
- Osteochondral Allograft, Ligament Reconstruction Tendon Interposition
- Keywords
- Allograft, Osteochondral Allograft, Arthritis
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteochondral AllograftProcedure or surgery
Also called Cartibend
The arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface.
Ligament Reconstruction Tendon InterpositionProcedure or surgery
During the LRTI, the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together.
| Study group | Role | What they receive |
|---|---|---|
| Ligament Reconstruction Tendon Interposition (LRTI) | Active comparator | Selected randomly, 100 patients will receive this treatment. During the LRTI (standard of care procedure), the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together. Receives: Procedure: Ligament Reconstruction Tendon Interposition |
| Osteochondral Allograft | Experimental | Selected randomly,100 patients will receive this treatment. In this procedure, the arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface, known as the 'Cartibend©' . Receives: Procedure: Osteochondral Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
The DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item questionnaire that includes 21 physical function items, 6 symptom items, and 3 social/role function items used to evaluate a patient's ability to perform upper extremity activities. Higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability).
Measured: Up to 1 year post-operatively
Secondary outcomes (2)
Score on the Thumb Disability Exam (TDX)
The TDX is a questionnaire that measures changes in thumb function and pain, specifically for those with basal joint arthritis.The TDX is scored on a scale of 0 to 100, with a higher score indicating a greater degree of disability in the thumb.
Measured: Up to 1 year post-operatively
Visual Analog Scale for pain (VAS)
The VAS is a validated technique that measures acute and chronic pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: Up to 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start14 Nov 2019
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Joint ArthritisStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melvin P Rosenwasser, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722537
- Sponsor's protocol ID
- AAAS2615
- Status last verified
- Apr 2026
- First submitted
- 25 Oct 2018
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
- ClinicalTrials.gov ID
- NCT03722537
- Acronym / sponsor ID
- AAAS2615
- Conditions
- Basal Joint Arthritis
- Keywords
- Allograft, Osteochondral Allograft, Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 Oct 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.
This is a study comparing the current standard of care surgical treatment to a newer surgical procedure involving the implantation of osteochondral allograft at the base of the thumb. Patients will be followed at 1, 3, 6 months and 1 year post-operatively.
Detailed description
Basal joint arthritis of the thumb is a common condition associated with considerable morbidity. Many non-operative and operative treatments have been described, but few multicenter prospective evidence based trials exist comparing standard treatments. This continuing search for consensus and improvement of best clinical practice has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Operative treatments range from osteotomy, partial or complete trapeziectomy with or without reconstruction of the ligaments, tendon interposition to arthrodesis, however the functional outcome varies. Allograft has been previously described in joint replacement / prosthetic implantation surgery in other areas of the body, however not in the thumb. The purpose of this study is to investigate using osteochondral allograft in the surgical intervention phase of treatment for patients with basal joint arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligament Reconstruction Tendon Interposition (LRTI) | Active comparator | Procedure: Ligament Reconstruction Tendon InterpositionSelected randomly, 100 patients will receive this treatment. During the LRTI (standard of care procedure), the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together. |
| Osteochondral Allograft | Experimental | Procedure: Osteochondral AllograftSelected randomly,100 patients will receive this treatment. In this procedure, the arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface, known as the 'Cartibend©' . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Indicated for operative management of basal joint arthritis
Key exclusion criteria (2 listed)
- Pregnant women/fetuses/neonates, prisoners
- Previously operated on for treatment of basal joint arthritis
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 |
|---|---|---|
| Osteochondral AllograftAlso: CartibendThe arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface. | Procedure or surgery | Osteochondral Allograft |
| Ligament Reconstruction Tendon InterpositionDuring the LRTI, the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together. | Procedure or surgery | Ligament Reconstruction Tendon Interposition (LRTI) |
Primary outcome
Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Time frame: Up to 1 year post-operatively
The DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item questionnaire that includes 21 physical function items, 6 symptom items, and 3 social/role function items used to evaluate a patient's ability to perform upper extremity activities. Higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability).
2 secondary outcomes
Score on the Thumb Disability Exam (TDX)
Time frame: Up to 1 year post-operatively
Visual Analog Scale for pain (VAS)
Time frame: Up to 1 year post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Melvin P Rosenwasser, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteochondral Allograft and Ligament Reconstruction Tendon Interposition in people with Basal Joint Arthritis, run by Columbia University 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melvin P Rosenwasser, MD (212-305-8036, mpr2@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire (time frame: Up to 1 year post-operatively). 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 8 Apr 2026.