Adaprev in Digital Flexor Tendon Repair

NCT01014494 | Unknown

• 1 other identifier: RN1008-0083
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 9

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.

Conditions

Tendon Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Active - Adaprev

EXPERIMENTAL

Adaprev (Class III medical device)

Device: Adaprev

Standard Care

NO INTERVENTION

No different treatment to normal

Interventions

Adaprev DEVICE

Class III Medical Device

Also known as: Product contains mannose-6-phosphate

Active - Adaprev

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Renovo: lead

Study Sites (9)

Mr P Gillespie

Addenbrooke's Hospital, Cambridge, Cambridge, CB2 0QQ, United Kingdom

RECRUITING

University Hospital of South Manchester NHS Foundation Trust

Manchester, Greater Manchester, M23 9LT, United Kingdom

RECRUITING

Mr F Schreuder

The Lister Hospital, Stevenage, Hertfordshire, United Kingdom

RECRUITING

Royal London Hospital, Barts and The London Hospital

London, London, E1 1BB, United Kingdom

RECRUITING

Royal Free Hospital

London, London, NW3 2QG, United Kingdom

RECRUITING

Chelsea & Westminster Hospital

London, London, SW10 9NH, United Kingdom

RECRUITING

Mr R Dunn

Salisbury District Hospital, Salisbury, SP2 8BJ, United Kingdom

RECRUITING

Mr D Warwick

Southampton General Hospital, Southampton, SO16 6YD, United Kingdom

RECRUITING

Abertawe Bro Morgannwg University Nhs Trust

Swansea, SA12 7BR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Tendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• John Hutchison, MBBS PhD

  Renovo Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 9, 2010

Record last verified: 2010-12

Locations

GB (9)