PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	30 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05412615
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Wrist Osteoarthritis

Arms & Interventions

Arms

Experimental: Meniscal Allograft with PRC

These patients will receive a tissue allograft with their wrist reconstruction procedure.

Placebo Comparator: PRC only

These patients will receive the standard proximal row carpectomy procedure.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Englewood, Colorado

Status

Recruiting

Address

UCHealth Steadman Hawkins Clinic Inverness

Englewood, Colorado, 80112

Site Contact

Emma Judge

[email protected]

720-872-4850

Clinical Trial Finder