This study is a prospective randomized controlled clinical study. After the novel Achilles tendon rupture repaired , patients were randomly divided into 4 groups according to immobilisation duration of 0, 2, 4, and 6 weeks, respectively. All patients underwent the same suture technique with a similar rehabilitation protocol and were examined clinically at 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks to study the difference in efficacy among the groups.
This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different immobilisation duration by dividing the patients into four groups according to immobilisation duration of 0, 2, 4, and 6 weeks after a similar suture technique. The primary outcome was the time of return to light sports activity (LSA). Secondary outcomes included range of motion (ROM) and single-legged heel rise height (SHRH). Data on operation time, complications, visual analogue pain scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, and Achilles tendon Total Rupture score (ATRS) were also collected. Demographic baseline data were analysed using one-way analysis of variance; outcome parameters were analysed using Kruskal-Wallis H test, and complications were analysed using Fisher's exact test. Statistical significance was considered at P ≤ 0.05. The inclusion criteria were patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique. The excluded criteria were patients with prior ATR and those without rehabilitation or follow-up outcomes. Other situations that affected patients' lower limb functions or tendon healing (e.g. autoimmune disease, diabetes mellitus, systemic corticosteroid treatment) were also excluded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
immobilisation duration of 2,4,6 week after suture of Achilles tendon
Peking University Third Hospital
Beijing, Beijing Municipality, China
The time of return to light sports activity
When the patients are able to do jogging or rapid walk after the surgery, the time will be recorded
Time frame: From operation to 1-year follow-up after the surgery
Range of motion (ROM) recovery time
The recovery time will be recorded when the ROM is similar to that of the uninjured side.
Time frame: From operation to 1-year follow-up after the surgery
Recovery time of the single-legged heel rise height (SHRH)
The heel rise height is measured as the distance from the ground to the heel when the patient lift the heel while keeping the knee straight. The recovery time is noted when the SHRH is similar to that of the opposite leg.
Time frame: From operation to 1-year follow-up after the surgery
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