Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome
概览
- 阶段
- 不适用
- 干预措施
- Carpal Tunnel Release with Platelet-Rich Plasma
- 疾病 / 适应症
- Carpal Tunnel Syndrome
- 发起方
- Michael Fredericson, MD
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Boston Carpal Tunnel Questionnaire
- 状态
- 终止
- 最后更新
- 上个月
概览
简要总结
This study assesses the potential benefit of adjuvant platelet-rich plasma (PRP) with carpal tunnel release (CTR) for patients with severe carpal tunnel syndrome (CTS). CTR is a rather common procedure performed and seems to be quite effective for those with moderate CTS, but a number of patients with severe CTS do not have quite the same response post-CTR. The investigators will recruit patients who fall into the severe CTS category and compare CTR with and without adjuvant PRP to see if PRP can improve outcomes of this common surgery.
详细描述
1. Study team recruits patients with severe CTS who meet inclusion and exclusion criteria in an outpatient hand surgery clinic. Patients will be consented by the research team if the patient agrees to participate in the research study. 2. This will be a single blinded study, and participants will have an equal chance to be placed in either group. Participants will be randomized using permuted block randomization predetermined by our dedicated orthopedic biostatistician into two study groups: those that undergo CTR with adjuvant intra-operative PRP and those that undergo CTR without adjuvant PRP. All participants will have a pre-operative electromyography/nerve conduction study (EMG/NCS). 3. Primary outcome measures (BCTQ and grip strength), and secondary outcome measures (PROMIS; 2 point discrimination - thumb, index finger and middle finger; key pinch; 3 finger pinch; and EMG/NCS results) will be collected and stored in REDCap at initial visit. BCTQ and PROMIS will actually be available online for patient to complete at the patient's convenience. 4. Patients will undergo CTR with or without adjuvant PRP (based on assigned study group). Patients will not know which group the subject is in (single blinded). 5. BCTQ and PROMIS will be collected online at 3 months and 6 months post-operatively. EMG/NCS will only be performed preoperatively and at 6 months post-operatively in the Sports Medicine clinic. At the 6-month visit, the investigators will also collect data on 2 point discrimination, grip strength, key pinch, and 3 finger pinch. 6. The investigators will store data in REDCap. 7. Data will be analyzed with the assistance of our biostatistician, and results will be written up.
研究者
Michael Fredericson, MD
Professor of Orthopaedic Surgery
Stanford University
入排标准
入选标准
- •Adult age 18 years and up.
- •Diagnosed with severe CTS based on EMG/NCS, meaning those with evidence of axonal loss (absent or low amplitude median sensory nerve action potential and/or absent or low amplitude median motor nerve action potential and/or evidence of abnormal spontaneous activity, reduced recruitment, or motor unit action potential changes on needle EMG of median innervated muscles).
排除标准
- •Younger than age 18 years (minor status).
- •Diagnosed with concomitant peripheral neuropathy.
- •Previous CTR on the affected side.
- •Have contraindications to PRP (platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability, septicemia, local infection at site of procedure, consistent use of NSAIDs within 48 hours of procedure, steroid injection at treatment site within 1 month, systemic use of steroids within 2 weeks, tobacco use, recent fever or illness, or cancer).
研究组 & 干预措施
CTR with PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
干预措施: Carpal Tunnel Release with Platelet-Rich Plasma
CTR without PRP
Carpal tunnel release without adjuvant platelet-rich plasma.
干预措施: Carpal Tunnel Release without Platelet-Rich Plasma
结局指标
主要结局
Boston Carpal Tunnel Questionnaire
时间窗: 6 months post-op
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
Grip Strength
时间窗: 6 months post-op
Measured with a dynamometer.
Boston Carpal Tunnel Questionnaire
时间窗: up to 1 month pre-op
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
Boston Carpal Tunnel Questionnaire
时间窗: 3 months post-op
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
Grip Strength
时间窗: up to 1 month pre-op
Measured with a dynamometer.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS)(6 months post-op)
- 2 Point Discrimination at Thumb(6 months post-op)
- 2 Point Discrimination at Index Finger(6 months post-op)
- 2 Point Discrimination at Middle Finger(6 months post-op)
- Key Pinch(6 months post-op)
- 3 Finger Pinch(6 months post-op)
- Median Motor Latency(6 months post-op)
- Median Motor Amplitude(6 months post-op)
- Median Sensory Latency(6 months post-op)
- Median Sensory Amplitude(6 months post-op)
- EMG of Abductor Pollicis Brevis(6 months post-op)
- Median Motor Latency(up to 1 month pre-op)
- Median Motor Amplitude(up to 1 month pre-op)
- Median Sensory Latency(up to 1 month pre-op)
- Median Sensory Amplitude(up to 1 month pre-op)
- 3 Finger Pinch(up to 1 month pre-op)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(up to 1 month pre-op)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(3 months post-op)
- 2 Point Discrimination at Thumb(up to 1 month pre-op)
- 2 Point Discrimination at Index Finger(up to 1 month pre-op)
- 2 Point Discrimination at Middle Finger(up to 1 month pre-op)
- Key Pinch(up to 1 month pre-op)
- EMG of Abductor Pollicis Brevis(up to 1 month pre-op)