PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial

PLoS One. 2014 Oct 23;9(10):e110735. doi: 10.1371/journal.pone.0110735. eCollection 2014.

Abstract

Background: Postoperative adhesions constitute a substantial clinical problem in hand surgery. Fexor tendon injury and repair result in adhesion formation around the tendon, which restricts the gliding function of the tendon, leading to decreased digit mobility and impaired hand recovery. This study evaluated the efficacy and safety of the peptide PXL01 in preventing adhesions, and correspondingly improving hand function, in flexor tendon repair surgery.

Methods: This prospective, randomised, double-blind trial included 138 patients admitted for flexor tendon repair surgery. PXL01 in carrier sodium hyaluronate or placebo was administered around the repaired tendon. Efficacy was assessed by total active motion of the injured finger, tip-to-crease distance, sensory function, tenolysis rate and grip strength, and safety parameters were followed, for 12 months post-surgery.

Results: The most pronounced difference between the treatment groups was observed at 6 months post-surgery. At this timepoint, the total active motion of the distal finger joint was improved in the PXL01 group (60 vs. 41 degrees for PXL01 vs. placebo group, p = 0.016 in PPAS). The proportion of patients with excellent/good digit mobility was higher in the PXL01 group (61% vs. 38%, p = 0.0499 in PPAS). Consistently, the PXL01 group presented improved tip-to-crease distance (5.0 vs. 15.5 mm for PXL01 vs. placebo group, p = 0.048 in PPAS). Sensory evaluation showed that more patients in the PXL01 group felt the thinnest monofilaments (FAS: 74% vs. 35%, p = 0.021; PPAS: 76% vs. 35%, p = 0.016). At 12 months post-surgery, more patients in the placebo group were considered to benefit from tenolysis (30% vs. 12%, p = 0.086 in PPAS). The treatment was safe, well tolerated, and did not increase the rate of tendon rupture.

Conclusions: Treatment with PXL01 in sodium hyaluronate improves hand recovery after flexor tendon repair surgery. Further clinical trials are warranted to determine the most efficient dose and health economic benefits.

Trial registration: ClinicalTrials.gov NCT01022242; EU Clinical Trials 2009-012703-25.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Female
  • Finger Injuries / drug therapy
  • Finger Injuries / physiopathology
  • Finger Injuries / surgery
  • Finger Joint / drug effects
  • Finger Joint / physiopathology
  • Hand / physiopathology*
  • Hand / surgery*
  • Hand Strength
  • Humans
  • Hyaluronic Acid / chemistry*
  • Lactoferrin / pharmacology
  • Lactoferrin / therapeutic use*
  • Male
  • Patient Compliance
  • Range of Motion, Articular / drug effects
  • Recovery of Function* / drug effects
  • Sensation / drug effects
  • Tendon Injuries / drug therapy*
  • Tendon Injuries / physiopathology
  • Tendon Injuries / surgery*
  • Treatment Outcome
  • Wound Healing / drug effects

Substances

  • PXL01 peptide
  • Hyaluronic Acid
  • Lactoferrin

Associated data

  • EudraCT/2009-012703-25
  • ClinicalTrials.gov/NCT01022242

Grants and funding

The study was financed by Pergamum AB. M. Mahlapuu is CSO of Pergamum, PhD. The funder provided support in the form of salary for author MM, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific role of this author is articulated in the 'author contributions' section. Dr. K. Wiklund is employed by Pharma Consulting Group Solutions AB. Pharma Consulting Group Solutions AB provided support in the form of salary for author KW, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific role of this author is articulated in the 'author contributions' section.