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Adaprev in Digital Flexor Tendon Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
Genders Eligible for Study:   All
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
Addenbrooke's Hospital, Cambridge, Cambridge, United Kingdom, CB2 0QQ
University Hospital of South Manchester NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M23 9LT
Mr F Schreuder
The Lister Hospital, Stevenage, Hertfordshire, United Kingdom
Mr R Dunn
Salisbury District Hospital, Salisbury, United Kingdom, SP2 8BJ
Mr D Warwick
Southampton General Hospital, Southampton, United Kingdom, SO16 6YD
Royal London Hospital, Barts and The London Hospital
London, United Kingdom, E1 1BB
Royal Free Hospital
London, United Kingdom, NW3 2QG
Chelsea & Westminster Hospital
London, United Kingdom, SW10 9NH
Abertawe Bro Morgannwg University Nhs Trust
Swansea, United Kingdom, SA12 7BR
Sponsors and Collaborators
Renovo
Investigators
Study Director: John Hutchison, MBBS PhD Renovo Ltd
  More Information

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 January 14, 2017