Adaprev in Digital Flexor Tendon Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Renovo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT01014494
First received: November 16, 2009
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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 Intervention
Tendon Injuries
Device: Adaprev

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Renovo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014494

Locations
United Kingdom
Mr P Gillespie Recruiting
Addenbrooke's Hospital, Cambridge, Cambridge, United Kingdom, CB2 0QQ
Contact: Patrick Gillespie    01223 274632    Patrick.gillespie@addenbrookes.nhs.uk   
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    Fred.schreuder@nhs.net   
Mr R Dunn Recruiting
Salisbury District Hospital, Salisbury, United Kingdom, SP2 8BJ
Contact: Roderick Dunn    01722 336262 ext 3555    sue.dubber@salisbury.nhs.uk   
Mr D Warwick Recruiting
Southampton General Hospital, Southampton, United Kingdom, SO16 6YD
Contact: David Warwick    023 8079 5212    davidjwarwick@btinternet.com   
Contact: Elaine Hayward    02380 794 989    elaine.hayward@suht.swest.nhs.uk   
Royal London Hospital, Barts and The London Hospital Recruiting
London, United Kingdom, E1 1BB
Contact: Kamal El-Ali    07986 693062    Kamal.El-Ali@bartsandthelondon.nhs.uk   
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    khchakrabarty@yahoo.com   
Contact: Beryl De Souza       bds@dr.com   
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
Renovo
Investigators
Study Director: John Hutchison, MBBS PhD Renovo Ltd
  More Information

No publications provided

Responsible Party: Harriet Wibberley, Senior Clinical Project Manager, Renovo
ClinicalTrials.gov Identifier: NCT01014494     History of Changes
Other Study ID Numbers: RN1008-0083
Study First Received: November 16, 2009
Last Updated: December 7, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014