NCT05412615 · University of Colorado, Denver
PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Meniscus Allograft Transplantation with Proximal Row Carpectomy
Supplementing the wrist reconstruction with a meniscal allograft to improve wrist function and pain scores.
PROCEDURE
Proximal Row Carpectomy
Standard proximal row carpectomy with no tissue or synthetic adjuncts
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- symptomatic wrist arthritis associated with SLAC or SNAC pathology
- Patients 30 years or older or 80 years or younger
Exclusion criteria
- Patients younger than 29 years or older than 80 years
- History of previous surgery related to wrist osteoarthritis
Where
- Englewood, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2025 · Source of record for eligibility and locations