PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis
ConditionWrist Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
symptomatic wrist arthritis associated with SLAC or SNAC pathology
Patients 30 years or older or 80 years or younger
Disqualifiers
Patients younger than 29 years or older than 80 years
History of previous surgery related to wrist osteoarthritis
Trial design
Design model
Single group
Treatments tested in this trial
Meniscus Allograft Transplantation with Proximal Row Carpectomy
Procedure/SurgerySupplementing the wrist reconstruction with a meniscal allograft to improve wrist function and pain scores.
Proximal Row Carpectomy
Procedure/SurgeryStandard proximal row carpectomy with no tissue or synthetic adjuncts
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Meniscal Allograft with PRCExperimental treatment 1 intervention
Group B: PRC onlyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Preoperatively2
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.
Time frame
2 weeks3
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.
Time frame
6 weeks4
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.
Time frame
3 monthsSecondary outcomes
1
Pain Score
Visual Analog Pain Score
Time frame
Preoperatively, up to 24 Months2
Radiographic joint spacing
Measurement of joint spacing in the wrist in millimeters.
Time frame
3 months, up to 24 Months3
MRI Joint Spacing
Wrist joint spacing measurements in millimeters using Magnetic resonance imaging (MRI)
Time frame
9 Months, 24 MonthsSponsors and contacts
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Source ClinicalTrials.gov