Adaprev in Digital Flexor Tendon Repair

Renovo

Status

Unknown

Conditions

Tendon Injuries

Treatments

Device: Adaprev

Study type

Interventional

Funder types

Industry

Identifiers

NCT01014494

RN1008-0083

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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