PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome
Trial ID or NCT#
NCT04811287
Status
NOT RECRUITING
Purpose
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.
Official Title
Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Adult age 18 years and up. 2. 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).
Exclusion Criteria:
- 1. Younger than age 18 years (minor status). 2. Diagnosed with concomitant peripheral neuropathy. 3. Previous CTR on the affected side. 4. 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).
Investigator(s)
Michael Fredericson, MD
Sports medicine physiatrist,
Sports medicine doctor,
Sports medicine surgeon
Professor of Orthopaedic Surgery
View on ClinicalTrials.gov
