Adaprev in Digital Flexor Tendon Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014494
Recruitment Status : Unknown
Verified December 2010 by Renovo.
Recruitment status was:  Recruiting
First Posted : November 17, 2009
Last Update Posted : December 9, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Tendon Injuries Device: Adaprev Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : September 2009
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Active - Adaprev
Adaprev (Class III medical device)
Device: Adaprev
Class III Medical Device
Other Name: Product contains mannose-6-phosphate
No Intervention: Standard Care
No different treatment to normal

Primary Outcome Measures :
  1. 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 Outcome Measures :
  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 [ Time Frame: 26 weeks post surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014494

United Kingdom
Mr P Gillespie Recruiting
Addenbrooke's Hospital, Cambridge, Cambridge, United Kingdom, CB2 0QQ
Contact: Patrick Gillespie    01223 274632   
University Hospital of South Manchester NHS Foundation Trust Recruiting
Manchester, Greater Manchester, United Kingdom, M23 9LT
Contact: Miss V C Lees    +44 (0) 161 291 6648      
Principal Investigator: Vivien C Lees         
Mr F Schreuder Recruiting
The Lister Hospital, Stevenage, Hertfordshire, United Kingdom
Contact: Mr Schreuder    01438 781162   
Mr R Dunn Recruiting
Salisbury District Hospital, Salisbury, United Kingdom, SP2 8BJ
Contact: Roderick Dunn    01722 336262 ext 3555   
Mr D Warwick Recruiting
Southampton General Hospital, Southampton, United Kingdom, SO16 6YD
Contact: David Warwick    023 8079 5212   
Contact: Elaine Hayward    02380 794 989   
Royal London Hospital, Barts and The London Hospital Recruiting
London, United Kingdom, E1 1BB
Contact: Kamal El-Ali    07986 693062   
Principal Investigator: Raj Ragoowansi         
Sub-Investigator: Kamal El Ali         
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Donald Dewar    020 7794 0500 ext 31302      
Principal Investigator: Donald Dewar         
Chelsea & Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
Contact: Mr Chakrabarty    020 8237 2777 ext 55490   
Contact: Beryl De Souza   
Principal Investigator: Kaushik Chakrabarty         
Sub-Investigator: Beryl De Souza         
Abertawe Bro Morgannwg University Nhs Trust Recruiting
Swansea, United Kingdom, SA12 7BR
Contact: Mr D Boyce    +44 (0) 1792 703722      
Principal Investigator: Mr D Boyce         
Sponsors and Collaborators
Study Director: John Hutchison, MBBS PhD Renovo Ltd

Responsible Party: Harriet Wibberley, Senior Clinical Project Manager, Renovo Identifier: NCT01014494     History of Changes
Other Study ID Numbers: RN1008-0083
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Tendon Injuries
Wounds and Injuries