Thumb OsteoarthritisARA:BJA-OANCT02958137
Arthroscopic Resection Arthroplasty of Carpometacarpal and/or Pantrapezial Osteoarthritis
An observational study of Thumb Osteoarthritis, run by Orthopaedic Specialist, PC, Davenport, IA.
Trial summary
Compare outcomes of ARA for isolated CMC OA versus to simultaneous ARA of CMC plus STT Read more about this study
- Who is it for?
- Ages 35 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Arthroscopic Resection Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2011
- Phase
- Observational
- 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 35 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting with basal joint arthritis who were scheduled to undergo arthroscopic resection arthroplasty of the CMC and/or STT joints.
Who may be able to join
- Primary cases of ARA for thumb BJA with isolated CMC ARA or simultaneous ARA of the CMC and STT joints.
Who cannot join
- Exclusions included 19 cases that received interposition materials that since have been shown to produce unfavorable postoperative inflammatory responses, (Orthadapt Bioimplant, Pegasus Biologics, Irvine, CA and Artimplant Artelon CMC-I Spacer, Small Bone Innovations, LLC, New York, NY), 6 cases that had prior CMC surgery, and 27 cases that underwent concomitant surgeries that would potentially effect outcome.
About this study
Official title: Arthroscopic Resection Arthroplasty of Basal Joint Arthritis: Comparing Outcomes of Isolated Carpometacarpal to Pantrapezial Disease
Compare outcomes of ARA for isolated CMC OA versus to simultaneous ARA of CMC plus STT
Read the detailed description
The purposes of this study were to report 1) long-term outcomes on a large series of patients that underwent arthroscopic resection arthroplasty (ARA) for thumb basal joint arthritis (BJA) and 2) to compare outcomes of ARA for isolated carpometacarpal osteoarthritis versus those undergoing simultaneous ARA of CMC plus the scaphotrapeziotrapezoid joint for pantrapezial disease.
Please note, all patients treated by Dr. Cobb for CMC and/or STT OA received the same treatment regardless of whether or not they chose to participate in the study. Patients who chose to enroll in the study received the same treatment as those who did not only their data was analyzed. Data collection is the same for those who do not participate, only their data is not analyzed.
- Conditions
- Thumb Osteoarthritis
- Being tested
- Arthroscopic Resection Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Resection ArthroplastyProcedure or surgery
Also called Arthroscopy
Surgical removal of the arthritic joint(s) using a minimally invasive technique.
| Study group | Role | What they receive |
|---|---|---|
| Isolated CMC | Arthroscopic Resection Arthroplasty of isolated CMC joint OA. Please note, this is standard practice of Dr. Cobb's for treatment of CMC and/or STT arthritis. Receives: Procedure: Arthroscopic Resection Arthroplasty | |
| Pantrapezial | Arthroscopic Resection Arthroplasty of simultaneous ARA of both the CMC and the STT joints. Please note, this is standard practice of Dr. Cobb's for treatment of CMC and/or STT arthritis. Receives: Procedure: Arthroscopic Resection Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength (pinch and grip)
Measured: Change from baseline to 2 year follow-up.
Secondary outcomes (2)
Satisfaction with Perceived Surgical Outcome
(0-5; 0 = not at all satisfied, 5 = completely satisfied)
Measured: Reported at 2 year postoperative follow-up
Pain
numerical rating scale, (0-10; 0 = no pain, 10 = worst imaginable pain)
Measured: Change from baseline to 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startJan 2004
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Specialist, PC, Davenport, IA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyson Cobb, MD, Orthopaedic Specialist, PC, Davenport, IA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958137
- Sponsor's protocol ID
- Osquadcities
- Acronym
- ARA:BJA-OA
- Status last verified
- Nov 2016
- First submitted
- 27 Oct 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: All patient health information was protected and complied with data privacy legal requirements. Personally identifiable patient information was removed from the data set prior to data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Resection Arthroplasty of Basal Joint Arthritis: Comparing Outcomes of Isolated Carpometacarpal to Pantrapezial Disease
- ClinicalTrials.gov ID
- NCT02958137
- Acronym / sponsor ID
- ARA:BJA-OA / Osquadcities
- Conditions
- Thumb Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Orthopaedic Specialist, PC, Davenport, IAUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Nov 2016 (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.
Compare outcomes of ARA for isolated CMC OA versus to simultaneous ARA of CMC plus STT
Detailed description
The purposes of this study were to report 1) long-term outcomes on a large series of patients that underwent arthroscopic resection arthroplasty (ARA) for thumb basal joint arthritis (BJA) and 2) to compare outcomes of ARA for isolated carpometacarpal osteoarthritis versus those undergoing simultaneous ARA of CMC plus the scaphotrapeziotrapezoid joint for pantrapezial disease.
Please note, all patients treated by Dr. Cobb for CMC and/or STT OA received the same treatment regardless of whether or not they chose to participate in the study. Patients who chose to enroll in the study received the same treatment as those who did not only their data was analyzed. Data collection is the same for those who do not participate, only their data is not analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated CMC | – | Procedure: Arthroscopic Resection ArthroplastyArthroscopic Resection Arthroplasty of isolated CMC joint OA. Please note, this is standard practice of Dr. Cobb's for treatment of CMC and/or STT arthritis. |
| Pantrapezial | – | Procedure: Arthroscopic Resection ArthroplastyArthroscopic Resection Arthroplasty of simultaneous ARA of both the CMC and the STT joints. Please note, this is standard practice of Dr. Cobb's for treatment of CMC and/or STT arthritis. |
Who may qualify
- Ages
- 35 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with basal joint arthritis who were scheduled to undergo arthroscopic resection arthroplasty of the CMC and/or STT joints.
Key inclusion criteria (1 listed)
- Primary cases of ARA for thumb BJA with isolated CMC ARA or simultaneous ARA of the CMC and STT joints.
Key exclusion criteria (1 listed)
- Exclusions included 19 cases that received interposition materials that since have been shown to produce unfavorable postoperative inflammatory responses, (Orthadapt Bioimplant, Pegasus Biologics, Irvine, CA and Artimplant Artelon CMC-I Spacer, Small Bone Innovations, LLC, New York, NY), 6 cases that had prior CMC surgery, and 27 cases that underwent concomitant surgeries that would potentially effect outcome.
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 |
|---|---|---|
| Arthroscopic Resection ArthroplastyAlso: ArthroscopySurgical removal of the arthritic joint(s) using a minimally invasive technique. | Procedure or surgery | Isolated CMC, Pantrapezial |
Primary outcome
Strength (pinch and grip)
Time frame: Change from baseline to 2 year follow-up.
2 secondary outcomes
Satisfaction with Perceived Surgical Outcome
Time frame: Reported at 2 year postoperative follow-up
Pain
Time frame: Change from baseline to 2 year follow-up
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 8 Nov 2016.
- Individual participant dataSharing planned: No. All patient health information was protected and complied with data privacy legal requirements. Personally identifiable patient information was removed from the data set prior to data analysis.
Related trials for Thumb Osteoarthritis
Recruiting
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Thumb Osteoarthritis
Active, not recruitingPhase 4
Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Osteoarthritis Thumb
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
RecruitingPhase 2
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
Thumb Osteoarthritis
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Thumb Osteoarthritis, run by Orthopaedic Specialist, PC, Davenport, IA.
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 1 inclusion and 1 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Strength (pinch and grip) (time frame: Change from baseline to 2 year follow-up.). 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 Nov 2016.