NCT04811287

PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Michael Fredericson, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Carpal Tunnel Syndrome
• PRP

Interventions

Type	Name	Description
DEVICE	Carpal Tunnel Release with Platelet-Rich Plasma	CTR is performed with adjuvant PRP placed intra-operatively.
PROCEDURE	Carpal Tunnel Release without Platelet-Rich Plasma	CTR is performed without adjuvant PRP placed intra-operatively.

Timeline

• Start date: 2021-10-15
• Primary completion: 2025-03-01
• Completion: 2025-07-01
• First posted: 2021-03-23
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study