Wrist OsteoarthritisNCT05412615
PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis
A study testing Meniscus Allograft Transplantation with Proximal Row Carpectomy and Proximal Row Carpectomy in people with Wrist Osteoarthritis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about the effect of adding tissue graft for wrist osteoarthritis reconstruction procedures. Previous studies have shown better allograft stability, and no documented foreign body reaction than with silicone and other synthetic materials. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Wrist Osteoarthritis
- What is being tested?
- Meniscus Allograft Transplantation with Proximal Row Carpectomy and Proximal Row Carpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Dec 2026
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic wrist arthritis associated with SLAC or SNAC pathology
- Patients 30 years or older or 80 years or younger
Who cannot join
- Patients younger than 29 years or older than 80 years
- History of previous surgery related to wrist osteoarthritis
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
UCHealth Steadman Hawkins Clinic Inverness
Englewood, Colorado, 80112
Emma Judge, 720-872-4850, emma.judge@cuanschutz.edu
About this study
Official title: Proximal Row Carpectomy With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis
This study plans to learn more about the effect of adding tissue graft for wrist osteoarthritis reconstruction procedures. Previous studies have shown better allograft stability, and no documented foreign body reaction than with silicone and other synthetic materials.
- Conditions
- Wrist Osteoarthritis
- Being tested
- Meniscus Allograft Transplantation with Proximal Row Carpectomy, Proximal Row Carpectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniscus Allograft Transplantation with Proximal Row CarpectomyProcedure or surgery
Supplementing the wrist reconstruction with a meniscal allograft to improve wrist function and pain scores.
Proximal Row CarpectomyProcedure or surgery
Standard proximal row carpectomy with no tissue or synthetic adjuncts
| Study group | Role | What they receive |
|---|---|---|
| Meniscal Allograft with PRC | Experimental | These patients will receive a tissue allograft with their wrist reconstruction procedure. Receives: Procedure: Meniscus Allograft Transplantation with Proximal Row Carpectomy |
| PRC only | Placebo comparator | These patients will receive the standard proximal row carpectomy procedure. Receives: Procedure: Proximal Row Carpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op
Participant wrist disability score will be assessed before and after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
Measured: Preoperatively
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 2 weeks
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
Measured: 2 weeks
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 weeks
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
Measured: 6 weeks
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 3 months
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
Measured: 3 months
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 months
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
Measured: 6 months
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 9 months
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
Measured: 9 months
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 12 months
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
Measured: 12 months
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 24 months
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
Measured: 24 months
Secondary outcomes (3)
Pain Score
Visual Analog Pain Score
Measured: Preoperatively, up to 24 Months
Radiographic joint spacing
Measurement of joint spacing in the wrist in millimeters.
Measured: 3 months, up to 24 Months
MRI Joint Spacing
Wrist joint spacing measurements in millimeters using Magnetic resonance imaging (MRI)
Measured: 9 Months, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412615
- Sponsor's protocol ID
- 21-3148
- Status last verified
- Feb 2025
- First submitted
- 6 Jun 2022
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Row Carpectomy With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis
- ClinicalTrials.gov ID
- NCT05412615
- Acronym / sponsor ID
- 21-3148
- Conditions
- Wrist Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jun 2022 (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 study plans to learn more about the effect of adding tissue graft for wrist osteoarthritis reconstruction procedures. Previous studies have shown better allograft stability, and no documented foreign body reaction than with silicone and other synthetic materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meniscal Allograft with PRC | Experimental | Procedure: Meniscus Allograft Transplantation with Proximal Row CarpectomyThese patients will receive a tissue allograft with their wrist reconstruction procedure. |
| PRC only | Placebo comparator | Procedure: Proximal Row CarpectomyThese patients will receive the standard proximal row carpectomy procedure. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic wrist arthritis associated with SLAC or SNAC pathology
- Patients 30 years or older or 80 years or younger
Key exclusion criteria (2 listed)
- Patients younger than 29 years or older than 80 years
- History of previous surgery related to wrist osteoarthritis
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 |
|---|---|---|
| Meniscus Allograft Transplantation with Proximal Row CarpectomySupplementing the wrist reconstruction with a meniscal allograft to improve wrist function and pain scores. | Procedure or surgery | Meniscal Allograft with PRC |
| Proximal Row CarpectomyStandard proximal row carpectomy with no tissue or synthetic adjuncts | Procedure or surgery | PRC only |
Primary outcome
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op
Time frame: Preoperatively
Participant wrist disability score will be assessed before and after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 2 weeks
Time frame: 2 weeks
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 weeks
Time frame: 6 weeks
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 3 months
Time frame: 3 months
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 months
Time frame: 6 months
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 9 months
Time frame: 9 months
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 12 months
Time frame: 12 months
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 24 months
Time frame: 24 months
Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question.
3 secondary outcomes
Pain Score
Time frame: Preoperatively, up to 24 Months
Radiographic joint spacing
Time frame: 3 months, up to 24 Months
MRI Joint Spacing
Time frame: 9 Months, 24 Months
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 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meniscus Allograft Transplantation with Proximal Row Carpectomy and Proximal Row Carpectomy in people with Wrist Osteoarthritis, run by University of Colorado, Denver 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 10 Feb 2025. 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. Some participants in this study may receive a placebo. 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 Fraser J Leversedge, MD (919-316-0616, fraser.leversedge@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op (time frame: Preoperatively). The study lists 8 primary outcomes in all. 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 10 Feb 2025.