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Clinical Trials/NCT05412615
NCT05412615
Recruiting
Not Applicable

Proximal Row Carpectomy With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

University of Colorado, Denver1 site in 1 country20 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wrist Osteoarthritis
Sponsor
University of Colorado, Denver
Enrollment
20
Locations
1
Primary Endpoint
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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: 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: 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: 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: 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: 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: 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.

Secondary Outcomes

  • Radiographic joint spacing(3 months, up to 24 Months)
  • Pain Score(Preoperatively, up to 24 Months)
  • MRI Joint Spacing(9 Months, 24 Months)

Study Sites (1)

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