Adaprev in Digital Flexor Tendon Repair

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01014494

Enrollment

Registered

2009-11-17

Start date

2009-09-30

Completion date

2011-12-31

Last updated

2010-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendon Injuries

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.

Interventions

DEVICEAdaprev

Class III Medical Device

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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.	26 weeks post surgery

Secondary

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	26 weeks post surgery

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026