Injuries and accidents Injury, Occupational Diseases, Poisoning
Conditions
Interventions
The trial will be conducted in approximately 20 hospitals. Patients listed for, or who have undergone surgical repair of zone I/II flexor tendons will be identified from hand clinics/ theatre or hand
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16 years old and over 2. Primary repair of zone I/II finger flexor tendon 3. Surgical repairs according to BSSH guidelines
Exclusion criteria
Exclusion criteria: 1. Patients with associated fractures requiring fixation or additional splintage 2. Tendon lacerations involving 3 or more fingers 3. Revascularization surgery and/or digital nerve reconstructions requiring a nerve graft 4. Presented for treatment more than 3 weeks following the original injury 5. Patients unable to consent or comply with the rehabilitation regime, for example, due to cognitive, psychological or physical disabilities 6. Co-enrolment in another hand trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean post-randomisation total score measured using the Patient Reported Wrist and Hand Evaluation (PRWHE) questionnaire at 6, 12, 26 and 52 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-reported outcomes: 1.1. Level of care received, function, pain and wellbeing measured using the Patient Evaluation Measure (PEM) at baseline, 6, 12, 26 and 52 weeks 1.2. Work productivity and activity impairment (WPAI) score measured at baseline, 6, 12, 26 and 52 weeks 1.3. Quality of life measured using the EuroQoL EQ-5D-5L questionnaire at baseline, 6, 12, 26 and 52 weeks 1.4. Details of any litigation/compensation for injury measured using a study-specific, single-item patient-reported questionnaire at 52 weeks 1.5. Change in general health measured using the global rating of change questionnaire at 6, 12, 26 and 52 weeks 1.6. Preferences for splint attributes (stated and revealed) and splint acceptability measured using study-specific surveys at baseline and 6 weeks 2. Clinical outcomes: 2.1. Range of movement measured using a goniometer and calculated as a Strickland score at baseline, 6, 12 and 26 weeks 2.2. Grip Strength measured using the GripAble tool at 12 and 26 weeks 2.3. Adherence to the splinting protocol measured using a temperature sensor inserted into the participants' splint at baseline and removed at splint removal, at 6 weeks 2.4. Complications and adverse events measured via case report forms completed by site staff throughout participant follow-up | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactHannah Berntsson
Outcome results
None listed