Clinical trial NCT01014494: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Tendon Injuries
Lead sponsor: Renovo
Sponsor class: INDUSTRY
First posted: 2009-11-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing.
timeFrame: 26 weeks post surgery
Secondary outcomes:
measure: 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
timeFrame: 26 weeks post surgery
Other outcomes:
Locations:
city: Addenbrooke's Hospital, Cambridge
country: United Kingdom
facility: Mr P Gillespie
state: Cambridge
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester NHS Foundation Trust
state: Greater Manchester
city: The Lister Hospital, Stevenage
country: United Kingdom
facility: Mr F Schreuder
state: Hertfordshire
city: Salisbury District Hospital
country: United Kingdom
facility: Mr R Dunn
state: Salisbury
city: Southampton General Hospital
country: United Kingdom
facility: Mr D Warwick
state: Southampton
city: London
country: United Kingdom
facility: Royal London Hospital, Barts and The London Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital
city: Swansea
country: United Kingdom
facility: Abertawe Bro Morgannwg University Nhs Trust
Study officials:
affiliation: Renovo Ltd
name: John Hutchison, MBBS PhD
role: STUDY_DIRECTOR
References: