Adaprev in Digital Flexor Tendon Repair

Tendon Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01014494
• Other study ID #: RN1008-0083
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2009
• Last updated: December 7, 2010
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2010
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tendon Injuries

Intervention

Device:
• Adaprev
Class III Medical Device

Locations

Country	Name	City	State
United Kingdom	Mr P Gillespie	Addenbrooke's Hospital, Cambridge	Cambridge
United Kingdom	Chelsea & Westminster Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	Royal London Hospital, Barts and The London Hospital	London
United Kingdom	University Hospital of South Manchester NHS Foundation Trust	Manchester	Greater Manchester
United Kingdom	Mr R Dunn	Salisbury District Hospital	Salisbury
United Kingdom	Mr D Warwick	Southampton General Hospital	Southampton
United Kingdom	Abertawe Bro Morgannwg University Nhs Trust	Swansea
United Kingdom	Mr F Schreuder	The Lister Hospital, Stevenage	Hertfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Renovo

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No