PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carpal Tunnel Syndrome
- PRP
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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.Masking: Single (Participant)Masking Description: See Model Description above.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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. This will be a single blinded study, and participants will have an ...
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. 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). 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. 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). BCTQ and PROMIS will be collected online at 3 months, 6 months, and 12 months post-operatively. EMG/NCS will only be performed preoperatively and at 12 months post-operatively in the Sports Medicine clinic. At these visits, the investigators will also collect data on 2 point discrimination, grip strength, key pinch, and 3 finger pinch. The investigators will store data in REDCap. Data will be analyzed with the assistance of our biostatistician, and results will be written up.
Tracking Information
- NCT #
- NCT04811287
- Collaborators
- Factor Medical
- Investigators
- Not Provided