Osteoarthrosis of the Carpometacarpal Joint of the ThumbNCT01376024
Study on Basal Joint Arthritis Prospective
An observational study of Osteoarthrosis of the Carpometacarpal Joint of the Thumb, run by Columbia University at 3 sites in United States.
Trial summary
The data in this prospective registry will be used 1) to define which surgical and nonoperative techniques are most effective at providing pain relief, restoring function, are cost effective, and patients are satisfied with their outcomes; and 2) to design focused clinical questions regarding the optimal treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthrosis of the Carpometacarpal Joint of the Thumb
- How many people
- 800 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Mar 2007to Feb 2027
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study subject population will consist of patients who are diagnosed with CMC arthritis of the thumb stages I, II, III, or IV. Recruitment of subjects will be the responsibility of the operating surgeon or a member of his clincal staff.
Who may be able to join
- Patients who have symptomatic basal joint arthritis.
- Patients who are capable of providing informed consent.
Who cannot join
- Patients younger than 18 years old at the time of enrollment.
- Patients with neuromuscular disease affecting the operated hand, not caused by the CMC operation.
- Patients with known inflammatory arthritic conditions, such as rheumatoid or psoriatic arthritis.
- Patients with a history of or current infection of the basal joint of the affected hand.
- Patients who are demented or are unable to provide informed consent.
- Patients unable to comply with study guidelines.
- Patients who have metacarpophalangeal joint hyperextension are NOT excluded. These patients will be followed and if they receive a capsulodesis or other procedure at the MCPJ at the same time as their basal joint arthroplasty this will be noted in their data records.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Terminated
Vanderbilt University Hospital
Nashville, Tennessee, 37232
- Recruiting
Columbia University/NY Presbyterian Hospital
New York, New York, 10032
Melvin Rosenwasser, MD
Melvin Rosenwasser, MD
- Terminated
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Prospective Study on Basal Joint Arthritis of the Thumb
The data in this prospective registry will be used 1) to define which surgical and nonoperative techniques are most effective at providing pain relief, restoring function, are cost effective, and patients are satisfied with their outcomes; and 2) to design focused clinical questions regarding the optimal treatment of basal joint arthritis of the thumb in future randomized controlled trials. There are no interventions or changes in patient care associated with this study.
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 multi-center prospective evidence based trials comparing standard treatments have been done. This continuing search for consensus of best clinical practices has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Through the systematic collection of data regarding patient-specific characteristics, treatment interventions, and longitudinal functional outcome measurements the investigators believe patient outcomes and satisfaction can improve through the elucidation of risk factors for disease progression, and the timing and selection of treatment modalities, either conservative or surgical, for any particular patient. The establishment of a multi-center clinical registry will greatly facilitate these goals.
The study hypothesizes that there exist effective non-operative and operative treatments for certain patient populations with basal joint arthritis of the thumb. There also exists a functionally superior, cost effective, and low risk non-operative or minimally invasive operative treatment regime to alleviate pain and slow the progression of disease in those with less advanced disease. Likewise, there is significant functional, health utility, and economic advantage to surgically treating advanced basal joint arthritis with one of the popularized procedures currently in practice.
- Keywords
- Carpometacarpal arthritis, Basal joint arthritis, CMC arthritis, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexion/extension range of MCP joint
Range of motion measured in degrees of the metacarpophalangeal (MCP) joint.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Flexion/extension range of IP joint
Range of motion measured in degrees of the interphalangeal (IP) joint.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Grip strength
This will be quantified with use of a Jamar dynamometer set in the second position.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Key-pinch strength
A 30-lb pinch dynamometer will used to determine lateral key-pinch strength.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Tip-pinch strength
A 30-lb pinch dynamometer will used to determine lateral tip-pinch strength.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes (4)
Average total costs per patient
Review or estimation of hospital and office bills including those for the prescribed therapy and/or splinting will be tallied for each patient.
Measured: Up to 1 year
Disability of Arm, Shoulder and Hand (DASH) score
A questionnaire designed to assess musculoskeletal disorders of the upper limbs.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
SF-36 questionnaire score
A questionnaire designed to validate general health: surveys physical functioning, performance in a physical role, performance in an emotional role, vitality, social functioning, bodily pain, general health perceptions, and mental health.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Prevalence of arthritis progression
Radiographs will be performed classify each patient within the Eaton 102 osteoarthritis staging system. Sequential radiographs will be examined for progression of joint abnormalities.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study start2 Mar 2007
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthrosis of the Carpometacarpal Joint of the ThumbStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Responsible party
- Sponsor
- Investigators
- Melvin P Rosenwasser, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376024
- Sponsor's protocol ID
- AAAC0826
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2011
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martou G, Veltri K, Thoma A. Surgical treatment of osteoarthritis of the carpometacarpal joint of the thumb: a systematic review. Plast Reconstr Surg. 2004 Aug;114(2):421-32. doi: 10.1097/01.prs.0000131989.86319.b1.
PubMed 15277809
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Basal Joint Arthritis of the Thumb
- ClinicalTrials.gov ID
- NCT01376024
- Acronym / sponsor ID
- AAAC0826
- Keywords
- Carpometacarpal arthritis, Basal joint arthritis, CMC arthritis, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Study start
- 2 Mar 2007 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Jun 2011 (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.
The data in this prospective registry will be used 1) to define which surgical and nonoperative techniques are most effective at providing pain relief, restoring function, are cost effective, and patients are satisfied with their outcomes; and 2) to design focused clinical questions regarding the optimal treatment of basal joint arthritis of the thumb in future randomized controlled trials. There are no interventions or changes in patient care associated with this study.
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 multi-center prospective evidence based trials comparing standard treatments have been done. This continuing search for consensus of best clinical practices has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Through the systematic collection of data regarding patient-specific characteristics, treatment interventions, and longitudinal functional outcome measurements the investigators believe patient outcomes and satisfaction can improve through the elucidation of risk factors for disease progression, and the timing and selection of treatment modalities, either conservative or surgical, for any particular patient. The establishment of a multi-center clinical registry will greatly facilitate these goals.
The study hypothesizes that there exist effective non-operative and operative treatments for certain patient populations with basal joint arthritis of the thumb. There also exists a functionally superior, cost effective, and low risk non-operative or minimally invasive operative treatment regime to alleviate pain and slow the progression of disease in those with less advanced disease. Likewise, there is significant functional, health utility, and economic advantage to surgically treating advanced basal joint arthritis with one of the popularized procedures currently in practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study subject population will consist of patients who are diagnosed with CMC arthritis of the thumb stages I, II, III, or IV. Recruitment of subjects will be the responsibility of the operating surgeon or a member of his clincal staff.
Key inclusion criteria (2 listed)
- Patients who have symptomatic basal joint arthritis.
- Patients who are capable of providing informed consent.
Key exclusion criteria (7 listed)
- Patients younger than 18 years old at the time of enrollment.
- Patients with neuromuscular disease affecting the operated hand, not caused by the CMC operation.
- Patients with known inflammatory arthritic conditions, such as rheumatoid or psoriatic arthritis.
- Patients with a history of or current infection of the basal joint of the affected hand.
- Patients who are demented or are unable to provide 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.
Primary outcome
Flexion/extension range of MCP joint
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Range of motion measured in degrees of the metacarpophalangeal (MCP) joint.
Flexion/extension range of IP joint
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Range of motion measured in degrees of the interphalangeal (IP) joint.
Grip strength
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
This will be quantified with use of a Jamar dynamometer set in the second position.
Key-pinch strength
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
A 30-lb pinch dynamometer will used to determine lateral key-pinch strength.
Tip-pinch strength
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
A 30-lb pinch dynamometer will used to determine lateral tip-pinch strength.
4 secondary outcomes
Average total costs per patient
Time frame: Up to 1 year
Disability of Arm, Shoulder and Hand (DASH) score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
SF-36 questionnaire score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Prevalence of arthritis progression
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
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 10 Jun 2026.
- Background: PubMed 15277809Martou G, Veltri K, Thoma A. Surgical treatment of osteoarthritis of the carpometacarpal joint of the thumb: a systematic review. Plast Reconstr Surg. 2004 Aug;114(2):421-32. doi: 10.1097/01.prs.0000131989.86319.b1.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthrosis of the Carpometacarpal Joint of the Thumb, run by Columbia University 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 2 inclusion and 7 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 10 Jun 2026. 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?
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?
Flexion/extension range of MCP joint (time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year). The study lists 5 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 NCT01376024, which also lists 1 linked publication.
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 10 Jun 2026.