Adaprev in Digital Flexor Tendon Repair

Renovo44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Tendon Injuries

Interventions

AdaprevDEVICE

Class III Medical Device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Mr P Gillespie

Addenbrooke's Hospital, Cambridge, Cambridge, United Kingdom

RECRUITING

University Hospital of South Manchester NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing.

Time frame: 26 weeks post surgery

Secondary Outcomes

The secondary endpoint will be an evaluation of the performance of Adaprev™ as measured by the range of motion of the treated finger at twenty six weeks after tendon repair

Time frame: 26 weeks post surgery

Data from ClinicalTrials.gov

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