Adaprev in Digital Flexor Tendon Repair

Not Applicable

• Conditions: Tendon Injuries
• Interventions: Device: Adaprev

• Registration Number: NCT01014494
• Lead Sponsor: Renovo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-09
• Primary Completion: 2011-11
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active - Adaprev	Adaprev	Adaprev (Class III medical device)

Primary Outcome Measures

Name	Time	Method
The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing.	26 weeks post surgery

Secondary Outcome Measures

Name	Time	Method
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	26 weeks post surgery

Trial Locations

Locations (9)

Mr R Dunn; 🇬🇧 Salisbury District Hospital, Salisbury, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

Mr P Gillespie; 🇬🇧 Addenbrooke's Hospital, Cambridge, Cambridge, United Kingdom

Mr D Warwick; 🇬🇧 Southampton General Hospital, Southampton, United Kingdom

University Hospital of South Manchester NHS Foundation Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom

Royal London Hospital, Barts and The London Hospital; 🇬🇧 London, United Kingdom

Chelsea & Westminster Hospital; 🇬🇧 London, United Kingdom

Abertawe Bro Morgannwg University Nhs Trust; 🇬🇧 Swansea, United Kingdom

Mr F Schreuder; 🇬🇧 The Lister Hospital, Stevenage, Hertfordshire, United Kingdom