Background 

Why are we doing this research? A national survey of open flexor tendon injuries in 2016 found a large majority of surgeons repaired both divided flexor tendons in zone 2. A more recent service evaluation, found this proportion had fallen to half.  Given the recent shift into routine surgical practice to leave Flexor Digitorum Superficialis (FDS) unrepaired and the lack of high quality randomised controlled trial evidence, there is an urgent need for a definitive trial on the repair of Flexor Digitorum Profundus (FDP) alone versus the repair of both FDP and FDS flexor tendons to inform clinical practice.

Research Aim: to determine the clinical and cost effectiveness of repairing FDP alone verses repair of both FDP and FDS for treatment of complete zone 2, single finger, flexor tendon injuries.

Study Design: Multi-centre, two-arm, non-inferiority, parallel group, randomised controlled trial with an internal pilot, economic evaluation and nested qualitative study.

Setting: up to 40 hospitals within the UK treating flexor tendon injuries and with facilities to support research activity.

Sample Size: 310 patients aged 16 years and over with an open flexor tendon injury within zone 2 only and require surgical repair. There will be 155 patients in each treatment arm. 

Primary Objective: to ascertain the patient reported clinical effectiveness of these interventions at 6 months using the Patient Evaluation Measure.

Secondary Objectives: Patient Reported Wrist/Hand Evaluation measure, surgical complications, need for further surgery, range of motion, grip strength, comparison of QALYs and cost effectiveness between the groups and a nested qualitative study exploring aspects of service delivery (e.g. anaesthetic preferences).

Intervention: Flexor Digitorum Profundus (FDP) is repaired only 

Control: Repair of both Flexor Digitorum Profundus (FDP) and Flexor Digitorum Superficialis (FDS)

Estimated Recruitment Period: 40 months (target date of first enrolment October 2022) 

Duration per Patient: 6 months 

Estimated Recruitment Period: 40 months (target date of first enrolment October 2022) 

Duration per Patient: 6 months 

Interested in taking part?

If you would like to take part please complete the Expression of Interest Form by clicking here or using the QR code below: