Adaprev in Digital Flexor Tendon Repair
Primary Purpose
Tendon Injuries
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Adaprev
Sponsored by
About this trial
This is an interventional prevention trial for Tendon Injuries
Eligibility 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
Sites / Locations
- Mr P GillespieRecruiting
- University Hospital of South Manchester NHS Foundation TrustRecruiting
- Mr F SchreuderRecruiting
- Mr R DunnRecruiting
- Mr D WarwickRecruiting
- Royal London Hospital, Barts and The London HospitalRecruiting
- Royal Free HospitalRecruiting
- Chelsea & Westminster HospitalRecruiting
- Abertawe Bro Morgannwg University Nhs TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active - Adaprev
Standard Care
Arm Description
Adaprev (Class III medical device)
No different treatment to normal
Outcomes
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01014494
Brief Title
Adaprev in Digital Flexor Tendon Repair
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 Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Renovo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active - Adaprev
Arm Type
Experimental
Arm Description
Adaprev (Class III medical device)
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
No different treatment to normal
Intervention Type
Device
Intervention Name(s)
Adaprev
Other Intervention Name(s)
Product contains mannose-6-phosphate
Intervention Description
Class III Medical Device
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hutchison, MBBS PhD
Organizational Affiliation
Renovo Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Mr P Gillespie
City
Addenbrooke's Hospital, Cambridge
State/Province
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Gillespie
Phone
01223 274632
Email
Patrick.gillespie@addenbrookes.nhs.uk
Facility Name
University Hospital of South Manchester NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miss V C Lees
Phone
+44 (0) 161 291 6648
First Name & Middle Initial & Last Name & Degree
Vivien C Lees
Facility Name
Mr F Schreuder
City
The Lister Hospital, Stevenage
State/Province
Hertfordshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mr Schreuder
Phone
01438 781162
Email
Fred.schreuder@nhs.net
Facility Name
Mr R Dunn
City
Salisbury District Hospital
State/Province
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roderick Dunn
Phone
01722 336262
Ext
3555
Email
sue.dubber@salisbury.nhs.uk
Facility Name
Mr D Warwick
City
Southampton General Hospital
State/Province
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Warwick
Phone
023 8079 5212
Email
davidjwarwick@btinternet.com
First Name & Middle Initial & Last Name & Degree
Elaine Hayward
Phone
02380 794 989
Email
elaine.hayward@suht.swest.nhs.uk
Facility Name
Royal London Hospital, Barts and The London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamal El-Ali
Phone
07986 693062
Email
Kamal.El-Ali@bartsandthelondon.nhs.uk
First Name & Middle Initial & Last Name & Degree
Raj Ragoowansi
First Name & Middle Initial & Last Name & Degree
Kamal El Ali
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Dewar
Phone
020 7794 0500
Ext
31302
First Name & Middle Initial & Last Name & Degree
Donald Dewar
Facility Name
Chelsea & Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mr Chakrabarty
Phone
020 8237 2777
Ext
55490
Email
khchakrabarty@yahoo.com
First Name & Middle Initial & Last Name & Degree
Beryl De Souza
Email
bds@dr.com
First Name & Middle Initial & Last Name & Degree
Kaushik Chakrabarty
First Name & Middle Initial & Last Name & Degree
Beryl De Souza
Facility Name
Abertawe Bro Morgannwg University Nhs Trust
City
Swansea
ZIP/Postal Code
SA12 7BR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mr D Boyce
Phone
+44 (0) 1792 703722
First Name & Middle Initial & Last Name & Degree
Mr D Boyce
12. IPD Sharing Statement
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Adaprev in Digital Flexor Tendon Repair
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