Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique.

Exclusion Criteria

patients with prior Achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment).
- an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion was less than 3.5 cm) .
- those without rehabilitation or follow-up outcomes.

Arm && Interventions

Group	Intervention	Description
suture of Achilles tendon without immobilisation	immobilisation duration	-
suture of Achilles tendon with immobilisation	immobilisation duration	-

Primary Outcome Measures

Name	Time	Method
The time of return to light sports activity	From operation to 1-year follow-up after the surgery	When the patients are able to do jogging or rapid walk after the surgery, the time will be recorded

Secondary Outcome Measures

Name	Time	Method
Recovery time of the single-legged heel rise height (SHRH)	From operation to 1-year follow-up after the surgery	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.
Range of motion (ROM) recovery time	From operation to 1-year follow-up after the surgery	The recovery time will be recorded when the ROM is similar to that of the uninjured side.

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