Adaprev in Digital Flexor Tendon Repair

A Randomized, Double Blind Clinical Investigation to Evaluate the Safety, Tolerability, and Preliminary Performance of Adaprev™ in Improving Recovery of Tendon Function in Subjects Undergoing Surgical Repair of Flexor Tendons in Zone II of the Hand

This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. Subjects are randomised to either Adaprev or standard care and attend visits for 26 weeks following surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical trial sites.

Inclusion Criteria:

- Subjects aged 18 years and above with complete division of the Flexor Digitorum Profundus (FDP) tendon in Zone II.

Exclusion Criteria:

• Subjects with additional complicated injuries
• Subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair
• Subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred.
• Subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial.
• Subjects with conditions which may delay healing.
• Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
• Females who are pregnant