Adaprev in Digital Flexor Tendon Repair

December 7, 2010 updated by: Renovo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
        • Contact:
          • Donald Dewar
          • Phone Number: 31302 020 7794 0500
        • Principal Investigator:
          • Donald Dewar
      • London, United Kingdom, E1 1BB
        • Recruiting
        • Royal London Hospital, Barts and The London Hospital
        • Contact:
        • Principal Investigator:
          • Raj Ragoowansi
        • Sub-Investigator:
          • Kamal El Ali
      • London, United Kingdom, SW10 9NH
        • Recruiting
        • Chelsea & Westminster Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kaushik Chakrabarty
        • Sub-Investigator:
          • Beryl De Souza
      • Swansea, United Kingdom, SA12 7BR
        • Recruiting
        • Abertawe Bro Morgannwg University Nhs Trust
        • Contact:
          • Mr D Boyce
          • Phone Number: +44 (0) 1792 703722
        • Principal Investigator:
          • Mr D Boyce
    • Cambridge
      • Addenbrooke's Hospital, Cambridge, Cambridge, United Kingdom, CB2 0QQ
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M23 9LT
        • Recruiting
        • University Hospital of South Manchester NHS Foundation Trust
        • Contact:
          • Miss V C Lees
          • Phone Number: +44 (0) 161 291 6648
        • Principal Investigator:
          • Vivien C Lees
    • Hertfordshire
      • The Lister Hospital, Stevenage, Hertfordshire, United Kingdom
    • Salisbury
      • Salisbury District Hospital, Salisbury, United Kingdom, SP2 8BJ
    • Southampton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
26 weeks post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
26 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renovo

Investigators

  • Study Director: John Hutchison, MBBS PhD, Renovo Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 17, 2009

Study Record Updates

Last Update Posted (Estimate)

December 9, 2010

Last Update Submitted That Met QC Criteria

December 7, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN1008-0083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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