PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

Wrist Osteoarthritis Clinical Trial

— PRC  

Official title:

Proximal Row Carpectomy With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05412615
• Other study ID #: 21-3148
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 88 Years

Eligibility

Inclusion Criteria:

• symptomatic wrist arthritis associated with SLAC or SNAC pathology

• Patients 30 years or older

Exclusion Criteria:

• Patients 29 years or younger

• History of previous surgery related to wrist osteoarthritis

Related Conditions & MeSH terms

• Osteoarthritis
• Wrist Osteoarthritis

Intervention

Procedure:
• Meniscus Allograft Transplantation with Proximal Row Carpectomy
Supplementing the wrist reconstruction with a meniscal allograft to improve wrist function and pain scores.
• Proximal Row Carpectomy
Standard proximal row carpectomy with no tissue or synthetic adjuncts

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Preoperatively
Primary	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.	2 weeks
Primary	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.	6 weeks
Primary	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.	3 months
Primary	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.	6 months
Primary	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.	9 months
Primary	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.	12 months
Primary	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.	24 months
Secondary	Pain Score	Visual Analog Pain Score	Preoperatively, up to 24 Months
Secondary	Radiographic joint spacing	Measurement of joint spacing in the wrist in millimeters.	3 months, up to 24 Months
Secondary	MRI Joint Spacing	Wrist joint spacing measurements in millimeters using Magnetic resonance imaging (MRI)	9 Months, 24 Months