Achilles Tendon RuptureNCT04663542
The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery
A study testing immobilization duration in people with Achilles Tendon Rupture, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired by our suture technique, patients were randomly divided into 4 groups, and the brace fixation time was 0, 2, 4 and 6 weeks, respectively, to study the difference in efficacy between the groups. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- immobilization duration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- acute closed single-legged complete Achilles tendon rupture
- age of 18 to 60 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yang Lv, M.D., +8610-82267010, zhouf@bjmu.edu.cn
Xiangyu Xu, M.D., +86-15210849431, 307542744@qq.com
About this study
Official title: A Prospective Randomized Controlled Clinical Trial on the Comparison of the Treatment Outcomes of Different Immobilization Times After the Repair of Achilles Tendon Rupture
This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired by our suture technique, patients were randomly divided into 4 groups, and the brace fixation time was 0, 2, 4 and 6 weeks, respectively, to study the difference in efficacy between the groups.
Read the detailed description
This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different immobilization times by dividing the patients into four groups-A, B, C, and D-based on the amount of immobilization time (0, 2, 4, and 6 weeks, respectively) that include a similar rehabilitation protocol. The inclusion criteria are patients with an acute closed single-legged complete Achilles tendon rupture, and an age of 18 to 60 years. The exclusion criteria are patients with prior Achilles tendon rupture or other situations that affect their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). Other exclusion criteria are an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion is less than 3.5 cm), or those without rehabilitation or follow-up outcomes. All patients will be treated surgically with the same suture technique and undergo a similar rehabilitation protocol after the brace is removed.
- Conditions
- Achilles Tendon Rupture
- Being tested
- immobilization duration
- Keywords
- immobilization duration, open surgery, early rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immobilization durationProcedure or surgery
brace immobilization duration after open surgery for Achilles tendon rupture
| Study group | Role | What they receive |
|---|---|---|
| 0-week immobilization | Experimental | 0-week brace immobilization after the surgery will be conducted. Receives: Procedure: immobilization duration |
| 2-week immobilization | Experimental | 2-week brace immobilization after the surgery will be conducted. Receives: Procedure: immobilization duration |
| 4-week immobilization | Other | 4-week brace immobilization after the surgery will be conducted. Receives: Procedure: immobilization duration |
| 6-week immobilization | Other | 6-week brace immobilization after the surgery will be conducted. Receives: Procedure: immobilization duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from operation to 1-year follow-up after the surgery
Secondary outcomes (2)
range of motion (ROM) recovery time
the recovery time will be recorded when the ROM is similar to that of the uninjured side.
Measured: 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.
Measured: from operation to 1-year follow-up after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Qiao, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663542
- Sponsor's protocol ID
- PekingUTH LY ATR
- Other IDs
- 81702127, 2018YFF0301100
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei Z, Cui Z, Cao Y, Li X, Fu Y, Bai L, Lv Y. Comparative analysis of different mobility aids in the early accelerated rehabilitation phase following acute achilles tendon repair surgery: a prospective cohort study. J Orthop Surg Res. 2026 Apr 27;21(1):279. doi: 10.1186/s13018-026-06881-6.
PubMed 42036692Cao Y, Li X, Cui Z, Lv Y, Si G. Open surgery and minimally invasive repair of acute Achilles tendon rupture: stratified outcomes based on immobilization duration in a prospective cohort study. J Orthop Surg Res. 2025 Jul 12;20(1):647. doi: 10.1186/s13018-025-06019-0.
PubMed 40652259Cao Y, Gao S, Cui Z, Fu Y, Bai L, Si G, Fan J, Lv Y, Zhou F. Comparison of different immobilisation durations following open surgery for acute achilles tendon rupture: a prospective cohort study. J Orthop Surg Res. 2024 Aug 21;19(1):497. doi: 10.1186/s13018-024-04970-y.
PubMed 39169350
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Clinical Trial on the Comparison of the Treatment Outcomes of Different Immobilization Times After the Repair of Achilles Tendon Rupture
- ClinicalTrials.gov ID
- NCT04663542
- Acronym / sponsor ID
- PekingUTH LY ATR
- Conditions
- Achilles Tendon Rupture
- Keywords
- immobilization duration, open surgery, early rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired by our suture technique, patients were randomly divided into 4 groups, and the brace fixation time was 0, 2, 4 and 6 weeks, respectively, to study the difference in efficacy between the groups.
Detailed description
This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different immobilization times by dividing the patients into four groups-A, B, C, and D-based on the amount of immobilization time (0, 2, 4, and 6 weeks, respectively) that include a similar rehabilitation protocol. The inclusion criteria are patients with an acute closed single-legged complete Achilles tendon rupture, and an age of 18 to 60 years. The exclusion criteria are patients with prior Achilles tendon rupture or other situations that affect their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). Other exclusion criteria are an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion is less than 3.5 cm), or those without rehabilitation or follow-up outcomes. All patients will be treated surgically with the same suture technique and undergo a similar rehabilitation protocol after the brace is removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0-week immobilization | Experimental | Procedure: immobilization duration0-week brace immobilization after the surgery will be conducted. |
| 2-week immobilization | Experimental | Procedure: immobilization duration2-week brace immobilization after the surgery will be conducted. |
| 4-week immobilization | Other | Procedure: immobilization duration4-week brace immobilization after the surgery will be conducted. |
| 6-week immobilization | Other | Procedure: immobilization duration6-week brace immobilization after the surgery will be conducted. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- acute closed single-legged complete Achilles tendon rupture
- age of 18 to 60 years.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immobilization durationbrace immobilization duration after open surgery for Achilles tendon rupture | Procedure or surgery | 0-week immobilization, 2-week immobilization, 4-week immobilization, 6-week immobilization |
Primary outcome
the time of return to light sports activity
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.
2 secondary outcomes
range of motion (ROM) recovery time
Time frame: from operation to 1-year follow-up after the surgery
recovery time of the single-legged heel rise height (SHRH)
Time frame: from operation to 1-year follow-up after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 42036692Wei Z, Cui Z, Cao Y, Li X, Fu Y, Bai L, Lv Y. Comparative analysis of different mobility aids in the early accelerated rehabilitation phase following acute achilles tendon repair surgery: a prospective cohort study. J Orthop Surg Res. 2026 Apr 27;21(1):279. doi: 10.1186/s13018-026-06881-6.
- Derived from this study: PubMed 40652259Cao Y, Li X, Cui Z, Lv Y, Si G. Open surgery and minimally invasive repair of acute Achilles tendon rupture: stratified outcomes based on immobilization duration in a prospective cohort study. J Orthop Surg Res. 2025 Jul 12;20(1):647. doi: 10.1186/s13018-025-06019-0.
- Derived from this study: PubMed 39169350Cao Y, Gao S, Cui Z, Fu Y, Bai L, Si G, Fan J, Lv Y, Zhou F. Comparison of different immobilisation durations following open surgery for acute achilles tendon rupture: a prospective cohort study. J Orthop Surg Res. 2024 Aug 21;19(1):497. doi: 10.1186/s13018-024-04970-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Qiao, M.D. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immobilization duration in people with Achilles Tendon Rupture, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Lv, M.D. (+86-18513112060, lvyang42@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time of return to light sports activity (time frame: from operation to 1-year follow-up after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04663542, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.