None listed
Conditions
Brief summary
Relative motion extension (RME) splinting is a new method of rehabilitation for extensor tendon repair that is simpler and easier than the current well-established early mobilisation treatment of dynamic extension splinting, however to date no studies have directly compared the two. This study aims to compare range of motion and functional outcomes, patient adherence and satisfaction, and complication rates between groups at 6 and 12 weeks after surgery, and to compare the cost-effectiveness of the two treatment methods. Up to 38 consenting participants with extensor tendon repair in zones V and VI (on the back of the hand) involving up to three fingers will be recruited from the Dunedin Hospital Orthopaedic service and randomised to either RME or dynamic splinting. Participants will be partially-blinded by not revealing to them the study hypothesis in full; independent hand therapists blinded to group allocation will assess outcomes at 6- and 12 weeks. Differences in mean values between groups will be compared using regression analysis carried out at the 5% level of significance, following the intention to treat principle. Cost analysis will be on a health utility basis. A finding of significantly better outcomes and/or cost-effectiveness with RME will result in practise change locally and internationally. Information from this study will help to avoid unnecessary time off work and the associated loss of wages and productivity, minimise the cost and burden of splinting, and improve outcomes. The incidence of extensor tendon injury in zones V and VI of the hand appears to be higher in Maori and Pacific people and therefore findings of this study are likely to be of particular significance to this population.
Interventions
Relative motion extension (RME) splinting employs two components; a volar static wrist extension orthosis and a digital orthosis in the manner of a ‘yoke’.
Within the first 10 days post-surgery a Hand Therapy appointment is arranged and administered with a Physiotherapist or Occupational Therapist with 3 years or more Hand Therapy training, and the RME digital and wrist orthoses (splints) along with a resting pan night splint are fitted. The resting pan splint is worn every night throughout the
Relative motion extension (RME) splinting employs two components; a volar static wrist extension orthosis and a digital orthosis in the manner of a ‘yoke’. Within the first 10 days post-surgery a Hand Therapy appointment is arranged and administered with a Physiotherapist or Occupational Therapist with 3 years or more Hand Therapy training, and the RME digital and wrist orthoses (splints) along with a resting pan night splint are fitted. The resting pan splint is worn every night throughout the 8-9 week intervention period. During Week 1-3 the RME digital splint and the wrist splint are worn together during waking hours. Participants are instructed to actively flex and extend their fingers as far as they can within the confines of the day time splints 10-20 times every 2 hours and use their hand for light functional activities. During Week 4-5 digital splinting and mobilisation continues as for Week 1-3, however participants are instructed to remove the wrist component only and mobilise the wrist from extension to flexion in a tenodesis pattern 10 times every two hours. When full wrist range of motion is achieved, the wrist orthosis is discontinued for most of the time and only worn for heavy activity. Week 6-9: Participants are instructed to wear the finger component only during activity, and to remove the orthosis for active finger flexion and extension 10 times every hour. When full finger (active) range of motion is achieved, the finger orthosis is discontinued. In order to optimise retention and adherence to intervention protocols, participants will be provided with petrol vouchers in recognition of the costs of attending the two follow-up assessments. Petrol vouchers will be provided at the rate of $20 for each assessment attended. In addition, for participants who live more than 20 km from the study locality and the follow-up assessment does not coincide with a follow-up Hand Therapy or Surgical appointment (and the participant is not eligible for Accident Compensation Corporation travel costs), petrol vouchers will be provided at the rate of 50c per km travelled. Adherence to splinting will be evaluated using a participant questionnaire completed retrospectively at 6-weeks.
Sponsors
Miranda Buhler
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
*Patients undergoing primary repair of the extensor tendon in zones V and/or VI of one or more digits at Dunedin Hospital. *Simple division of 50% to 100% of the tendon as determined intra-operatively by the surgeon *Surgical repair suitable for early mobilisation. *Able to provide written informed consent.
Exclusion criteria
*Complex multi-tissue injury e.g. unstable fracture; significant skin loss; concurrent flexor tendon repair; replantation or revascularisation. *Extensor tendon repair to more than three digits *Extensor tendon repair to the thumb *Age under 16 years *Co-existing rheumatologic illness *Individual factors such as inability to adhere to the intervention or significant co-morbidity.
Outcome results
None listed