Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
NCT Number: NCT04956614
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100191, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
immobilisation duration of 2,4,6 week after suture of Achilles tendon
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Peking University Third Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05676632
Achilles Tendon Rupture
Leicester, United Kingdom
View Trial DetailsNCT05304819
Achilles Tendon Rupture
Penrith, United Kingdom
View Trial DetailsNCT05683080
Achilles Tendon Rupture
Leicester, United Kingdom
View Trial DetailsNCT03525964
Achilles Tendon Rupture
Hvidovre, Denmark
View Trial Details