None listed
Conditions
Brief summary
Achilles tendon rupture is a common injury but to date there is no consensus with regards to the optimal conservative management strategy. For surgically managed Achilles tendon rupture guidelines support immediate weight bearing in functional orthotics due to the superior functional and clinical outcomes. We aim to compare the use of immediate weightbearing in functional orthotic braces versus standard non weight bearing management for non-operatively managed Achilles tendon rupture. All patients presenting to Wellington Regional Hospital with Achilles tendon rupture will be screened for eligibility for the study. Included patients will be randomised to standard therapy in a non-weight bearing Equinus cast or a weight bearing VACOped orthotic brace. This study will recruit 86 patients to each study arm. ATRS scores, VR-12 quality of life scores and complication rates will be collected at 3, 6, and 12 months post injury. Results will be analysed on an intention to treat basis.
Interventions
The intervention involves application of a VACOped boot (Oped Ag Ltd, Germany) and commencement of immediate weight bearing after achilles tendon rupture. The boot will be applied in the orthopaedic clinic at a regional hospital by trained staff members and will be worn continuously for the subsequent 8 weeks. Trial participants will be reviewed every 2 weeks for the duration of time in this orthotic boot.
1. Immediate Weight bearing is weight bearing from the time the orthotic is applied,
The intervention involves application of a VACOped boot (Oped Ag Ltd, Germany) and commencement of immediate weight bearing after achilles tendon rupture. The boot will be applied in the orthopaedic clinic at a regional hospital by trained staff members and will be worn continuously for the subsequent 8 weeks. Trial participants will be reviewed every 2 weeks for the duration of time in this orthotic boot. 1. Immediate Weight bearing is weight bearing from the time the orthotic is applied, and as per our inclusion criteria the maximum time after injury to weight bearing in the orthotic will be 72hrs. 2. The boot has a locking function which prevents removal by trial participants. If this lock has been tampered with in order to remove the boot this will become apparent at the clinic appointments. 3. Weight bearing will be complete weight bearing as tolerated. Complete weight bearing will be encouraged as soon as patients are able.
Sponsors
Mr Giles Foley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Presenting within 72hrs of injury Isolated unilateral injury Closed injury Aged 16 or older
Exclusion criteria
none
Outcome results
None listed