Surgery for flexor tendon injuries Surgery
Conditions
Interventions
Current intervention as of 09/06/2023:
Multicentre, single-blinded, feasibility RCT with 2 parallel groups (WALANT Vs. GA/RA). Randomisation will be performed by minimisation technique with an element
Sponsors
Royal Free London NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults >=18 years old 2. Clinical diagnosis of acute flexor tendon injury (100% transected) involving Flexor digitorum profundus and/or Flexor digitorum superficialis, and/or Flexor pollicis longus of the hand 3. Single digit or two digits injury 4. Patient understands and is willing to participate and can comply with follow up regime
Exclusion criteria
Exclusion criteria: 1. Tendon not amendable to primary repair (gross wound contamination, segmental tendon loss, associated fractures or mangled hand injuries) 2. Secondary tendon repair or reconstruction 3. History of allergy to Local anaesthetic (LA) 4. Refusal to have LA or deemed non-cooperative to be performed without sedation 5. Pre-existing deformity of finger or hand 6. High risk for GA or not fit for surgery (American society of anaesthesiologist grade >4)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 09/06/2023: 1. Recruitment rate of the trial measured over 16 months (duration of recruitment) 2. Support for the trial from involved clinicians assessed through qualitative interviews over the duration of the trial 3. Equipoise amongst clinicians and patients assessed through qualitative interviews over the duration of the trial 4. Rate of participant withdrawal/drop-out from the study assessed throughout the duration of the trial _____ Previous primary outcome measure: Recuitment rate measured using patient records at end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/06/2023: 1. Proportion with good functional outcome measured using Total Active Motion (TAM) score with a goniometer at 1, 3 and 6 months 2.Grip strength measured using a dynamometer at 1, 3, and 6 months. 3. Pinch strength measured using a pinch gauge at 1, 3, and 6 months 4. Post-operative finger oedema assessed by measuring finger circumference at 1, 3, and 6 months 5. Patient-reported outcome assessed using the Michigan Hand Outcomes Questionnaire (MHQ) at 1, 3 and 6 months 6. Productivity impact assessed using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at baseline, 1, 3 and 6 months 7. Health-related quality of life assessed using the EQ-5D-5L questionnaire at baseline, 1, 3 and 6 months 8. Post-operative pain assessed using visual analogue score (VAS) tool immediately post-operatively 9. Incidence of tendon ruptures following repair assessed clinically at 1, 3 and 6 months 10. Incidence of tenolysis assessed clinically at 6 months 11. Incidence of overall complications at 6 months 12. Incidence of adverse events assessed throughout the duration of the trial 13. Healthcare resource use assessed through micro-costing analysis throughout the duration of the trial _____ Previous secondary outcome measures: 1. Patient reported Health-related quality of life questionnaire (EQ-5D-5L) at 1 and 3 months after surgery 2. Functional assessment of hand - recorded using Total active motion score at 3 - 5 days after surgery 3. Change of dressing measured using patient records at end of study 4. Hand therapy measured using patient records at end of study | — |
Countries
England, United Kingdom
Outcome results
None listed