Head Surgery

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

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

Wiig ME1, Dahlin LB2, Fridén J3, Hagberg L4, Larsen SE5, Wiklund K6, Mahlapuu M7.

Author information

• 1Department of Surgical Science, Hand Surgery, Uppsala University, Uppsala, Sweden; Uppsala University Hospital, Uppsala, Sweden.
• 2Department of Clinical Sciences Malmö - Hand Surgery, Lund University, Skåne University Hospital, Malmö, Sweden.
• 3Department of Hand Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.
• 4Department of Hand Surgery, Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
• 5Department for Orthopaedics, Unit for Hand Surgery, Odense University Hospital, Odense, Denmark.
• 6Pharma Consulting Group Solutions AB, Uppsala, Sweden.
• 7Pergamum AB, Stockholm, Sweden.

 

Abstract

BACKGROUND: Postoperative adhesions constitute a substantial clinical problem in hand surgery. Flexor 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.