Achilles Tendon RuptureNCT04912154
The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery
A study testing Rehabilitation protocol 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 , patients were randomly divided into 2 groups, and the rehabilitation protocol was traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring , respectively, to… 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?
- Rehabilitation protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Jun 2023
- 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
Yang Lv, M.D., +8601082267010, lvyang42@126.com
Yuan Cao, M.M., +8601082267010, cy6415@126.com
About this study
Official title: A Prospective Randomized Controlled Clinical Trial on the Comparison of Traditional Rehabilitation Protocol and Accelerated Rehabilitation Protocol Under Ultrasonic Monitoring for Achilles Tendon Rupture
This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired , patients were randomly divided into 2 groups, and the rehabilitation protocol was traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring , 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 rehabilitation protocols by dividing the patients into two groups-based on the traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring after a similar suture technique. 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.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Rehabilitation protocol
- Keywords
- traditional rehabilitation protocol, accelerated rehabilitation protocol, ultrasonic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation protocolProcedure or surgery
Rehabilitation protocol after open surgery for Achilles tendon rupture
| Study group | Role | What they receive |
|---|---|---|
| Traditional rehabilitation protocol | Experimental | Traditional rehabilitation protocol after the surgery will be conducted Receives: Procedure: Rehabilitation protocol |
| Accelerated rehabilitation protocol | Active comparator | Accelerated rehabilitation protocol under ultrasonic monitoring after the surgery will be conducted Receives: Procedure: Rehabilitation protocol |
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 posted3 Jun 2021
- Study start1 May 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 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
- NCT04912154
- Sponsor's protocol ID
- PekingUTH LYCY ATR
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. 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 Traditional Rehabilitation Protocol and Accelerated Rehabilitation Protocol Under Ultrasonic Monitoring for Achilles Tendon Rupture
- ClinicalTrials.gov ID
- NCT04912154
- Acronym / sponsor ID
- PekingUTH LYCY ATR
- Conditions
- Achilles Tendon Rupture
- Keywords
- traditional rehabilitation protocol, accelerated rehabilitation protocol, ultrasonic monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 3 Jun 2021 (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 , patients were randomly divided into 2 groups, and the rehabilitation protocol was traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring , 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 rehabilitation protocols by dividing the patients into two groups-based on the traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring after a similar suture technique. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional rehabilitation protocol | Experimental | Procedure: Rehabilitation protocolTraditional rehabilitation protocol after the surgery will be conducted |
| Accelerated rehabilitation protocol | Active comparator | Procedure: Rehabilitation protocolAccelerated rehabilitation protocol under ultrasonic monitoring 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 |
|---|---|---|
| Rehabilitation protocolRehabilitation protocol after open surgery for Achilles tendon rupture | Procedure or surgery | Accelerated rehabilitation protocol, Traditional rehabilitation protocol |
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 3 Jun 2021.
- 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 Rehabilitation protocol 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 3 Jun 2021. 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. (+8682267010, 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?
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 3 Jun 2021.