Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: suture of Achilles tendon without immobilisation
|
Device: immobilisation duration
immobilisation duration of 2,4,6 week after suture of Achilles tendon
|
| Experimental: suture of Achilles tendon with immobilisation
|
Device: immobilisation duration
immobilisation duration of 2,4,6 week after suture of Achilles tendon
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
Other Outcome Measures
- visual analogue scale (VAS) [2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery]
VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain. VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain.
- American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score [2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery]
The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.
- the Achilles tendon Total Rupture Score (ATRS) [2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery]
The ATRS includes 10 items; each item has a score ranging between 0 and 10 on a Likert scale, with 100 indicating no major limitations.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Third Hospital | Beijing | Beijing | China | 100191 |
Sponsors and Collaborators
- Peking University Third Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LM2020252