PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

NCT04811287 | Terminated Results FDA Device

• 1 other identifier: 59044
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome; PRP

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire

  Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe.

  up to 1 month pre-op

• Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire

  Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe.

  3 months post-op

• Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire

  Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe.

  6 months post-op

• Grip Strength

  Measured with a dynamometer.

  up to 1 month pre-op

• Grip Strength

  Measured with a dynamometer.

  6 months post-op

Secondary Outcomes (23)

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  up to 1 month pre-op

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  3 months post-op

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  6 months post-op

• 2 Point Discrimination at Thumb

  up to 1 month pre-op

• 2 Point Discrimination at Thumb

  6 months post-op

Study Arms (2)

CTR with PRP

ACTIVE COMPARATOR

Carpal tunnel release with adjuvant platelet-rich plasma.

Device: Carpal Tunnel Release with Platelet-Rich Plasma

CTR without PRP

PLACEBO COMPARATOR

Carpal tunnel release without adjuvant platelet-rich plasma.

Procedure: Carpal Tunnel Release without Platelet-Rich Plasma

Interventions

Carpal Tunnel Release without Platelet-Rich Plasma PROCEDURE

CTR is performed without adjuvant PRP placed intra-operatively.

CTR without PRP

Carpal Tunnel Release with Platelet-Rich Plasma DEVICE

CTR is performed with adjuvant PRP placed intra-operatively.

CTR with PRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Michael Fredericson, MD: lead

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

Related Publications (1)

• Trull-Ahuir C, Sala D, Chismol-Abad J, Vila-Caballer M, Lison JF. Efficacy of platelet-rich plasma as an adjuvant to surgical carpal ligament release: a prospective, randomized controlled clinical trial. Sci Rep. 2020 Feb 7;10(1):2085. doi: 10.1038/s41598-020-59113-0.

  PMID: 32034241 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Limitations and Caveats

Early termination led to a small number of participants analyzed.

Results Point of Contact

• Title: Michael Fredericson, MD
• Organization: Stanford University

emmedina@stanford.edu

(650) 721-1446

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: See Model Description above.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 23, 2021
• Study Start: October 15, 2021
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 30, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Locations

US (1)