Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Modified Mayo Wrist Score - Pain Score
研究概览
简要总结
The objective of this study is to compare outcomes and functionality measures of subjects treated with platelet rich plasma (PRP) after arthroscopic debridement of triangular fibrocartilage complex (TFCC) tears to subjects treated with arthroscopic debridement alone.
详细描述
Patients with triangular fibrocartilage complex (TFCC) tears will undergo treatment with arthroscopic debridement, as is standard of care, followed by treatment with platelet rich plasma (PRP) (24 subjects) versus no treatment with PRP (24 subjects). Outcome measures will include Modified Mayo Wrist scores (pain scale scores, grip strength, wrist range of motion, functional status) and Patient-rated Wrist Evaluation (PRWE) scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female >18 years of age
- •triangular fibrocartilage complex (TFCC) tear requiring surgical intervention
- •Be willing to undergo arthroscopic debridement and injection with platelet-rich plasma (PRP)
- •Be in good health other than the TFCC tear
- •Have realistic expectations of surgical results
- •Understand and be willing to follow all aspects of the study protocol and have signed and dated the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed
排除标准
- •Have collagen-vascular, connective tissue, or bleeding disorders
- •Be a smoker or have smoked in last 2 months
- •Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- •Have regional sympathetic dystrophy
- •Be pregnant, lactating or expecting to be within the next 24 months
- •Currently have an alcohol/substance abuse problem or have had a relapse within one year to screening visit
- •Have an abscess or infection at the time of surgery
- •Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
研究组 & 干预措施
Platelet-rich Plasma (PRP) group
Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated intraoperatively with platelet-rich plasma (PRP) (24 subjects).
Intervention: use of Cascade device; Autologous Fibrin & Platelet System; once processed, the platelet-rich plasma (PRP)is injected into the debrided wrist
干预措施: Platelet-rich Plasma (PRP) (Device)
Standard Treatment group
Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will undergo treatment, as is standard of care, followed by no treatment with platelet-rich plasma (PRP)(24 subjects).
Intervention: No platelet-rich plasma (PRP) injection into debrided wrist
干预措施: Standard Arthroscopic Debridement (Other)
结局指标
主要结局
Modified Mayo Wrist Score - Pain Score
时间窗: Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1
Modified Mayo Wrist score - Mean Pain score change assessment from pre to post-op: 0 (minimum/total; severe to intolerable)-25 (maximum/total; no pain) point scale
Patient-rated Wrist Evaluation (PRWE) Scores
时间窗: change from pre to post-op
The Patient-rated Wrist Evaluation is a 15 item patient-reported questionnaire to assess change from pre to post-op that asks the patient to rate their pain and function on a 10-point scale. 0 (minimum) means no pain/did not experience functional difficulties and 10 (maximum) means the worst pain/difficulty to function. Total minimum is 0 and total maximum for this scale measure is 150. Compare Mean patient-rated Wrist Evaluation outcome scores from pre-op to post-op.
Modified Mayo Wrist Score - Range of Motion Score
时间窗: Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.
Modified Mayo Wrist score - Range of motion score: Assessment of change from pre to post-op in patient's range of motion (percentage of normal) on a 0 (minimum/total)-100% (maximum/total) scale between mean patient score of patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement.
Modified Mayo Wrist Score - Grip Strength Score
时间窗: Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.
Modified Mayo Wrist score - Grip strength score: A change in grip strength from pre to post-op (percentage of normal) - on 0 (minimum/total)-100% (maximum/total) scale between patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement. Compare mean (percentage of normal) Grip strength scores from pre-op to post-op.
Modified Mayo Wrist Score - Functional Status Score
时间窗: Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.
Modified Mayo Wrist score - Functional status score: An assessment to review mean change from pre to post-op) 0 (minimum)-25 (maximum) point scale; a score of 0 denotes patient's inability to work because of pain and 25 denotes patients ability to work/return to regular employment
次要结局
未报告次要终点
研究者
David Kulber, MD
Principal Investigator
Cedars-Sinai Medical Center