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临床试验/NCT05412615
NCT05412615招募中不适用

Proximal Row Carpectomy With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • symptomatic wrist arthritis associated with SLAC or SNAC pathology
  • Patients 30 years or older or 80 years or younger

排除标准

  • Patients younger than 29 years or older than 80 years
  • History of previous surgery related to wrist osteoarthritis

结局指标

主要结局

DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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