Acute Rupture of Achilles Tendon (Disorder)NCT04465994
Comparison of Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture
An observational study of Acute Rupture of Achilles Tendon (Disorder), run by Peking University Third Hospital at 1 site in China.
Trial summary
This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, aiming to compare the mid-term curative effect of primary repair and gastrocnemius turn-down flaps and guide clinical decision. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Acute Rupture of Achilles Tendon (Disorder)
- What is being tested?
- gastrocnemius turn-down flaps
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2020to 5 May 2020
- Phase
- Observational
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, including 68 male patients and 6 female patients. The average age is 36 years.
Who may be able to join
- history of Achilles tendon injury
- within two weeks of injury
- inability to single heel rise
- more than one year of follow-up
- age under 65
Who cannot join
- open Achilles tendon rupture
- Achilles tendon terminal disease
- rerupture of Achilles tendon
- history of local corticosteroid injection around the Achilles tendon
- accompanied by fracture, vascular or nerve damage
- not available for regular follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Univerisity Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Comparison of Mid-term Curative Effect After Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture
This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, aiming to compare the mid-term curative effect of primary repair and gastrocnemius turn-down flaps and guide clinical decision.
Read the detailed description
Objective: To explore the surgical methods and observe the med-term curative effect of primary repair and gastrocnemius turn-down flaps for acute Achilles tendon rupture, so as to guide clinical decision. Methods: This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, whose surgeries was completed by the sponsor with either primary repair or gastrocnemius turn-down flaps. The recovery and motor function of the patients were followed up by outpatient clinic and telephone at 3 months, 6 months, 12 months and 24 months after operation, respectively, so as to statistically analyze the med-term curative effects of two surgeries. Specific indicators include: Visual Analogue Scale, American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score, The Victorian Institute of Sport Assessment-Achilles, The Achilles tendon Total Rupture Score, the Tegner Activity Score, Biodex isokinetic dynamometer system, Postoperative rehabilitation index and complications.
- Being tested
- gastrocnemius turn-down flaps
- Keywords
- Achilles Tendon, Acute injury, Primary repair, gastrocnemius turn-down flaps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrocnemius turn-down flapsProcedure or surgery
We classified the patients with acute achilles tendon rupture by type of surgery. The group who received the gastrocnemius turn-down flaps is the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| primary repair | Patients with acute achilles tendon ruptures who received the treatment of primary repair. | |
| gastrocnemius turn-down flaps | Patients with acute achilles tendon ruptures who received the treatment of gastrocnemius turn-down flaps. Receives: Procedure: gastrocnemius turn-down flaps |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Visual Analogue Scale
The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome.
Measured: from pre-surgery to two years after surgery
change of American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome.
Measured: from pre-surgery to two years after surgery
change of The Victorian Institute of Sport Assessment-Achilles
The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score.
Measured: from pre-surgery to two years after surgery
change of The Achilles tendon Total Rupture Score
The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score.
Measured: from pre-surgery to two years after surgery
change of the Tegner Activity Score
The Tegner activity scale was first described in 1985 and initially designed for physician administration after ACL and meniscal injuries. To date, the Tegner activity score has been a frequently used patient-administered activity rating system for patients with various knee disorders. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Measured: from pre-surgery to two years after surgery
Biodex
Biodex isokinetic dynamometer system
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
complications
rerupture, infection, wound scar
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start5 Jan 2020
- Primary completion5 Feb 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Rupture of Achilles Tendon (Disorder)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingfang Ao, MD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465994
- Sponsor's protocol ID
- M2019465
- Status last verified
- Jun 2020
- First submitted
- 27 Jun 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mid-term Curative Effect After Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture
- ClinicalTrials.gov ID
- NCT04465994
- Acronym / sponsor ID
- M2019465
- Keywords
- Achilles Tendon, Acute injury, Primary repair, gastrocnemius turn-down flaps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 10 Jul 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 retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, aiming to compare the mid-term curative effect of primary repair and gastrocnemius turn-down flaps and guide clinical decision.
Detailed description
Objective: To explore the surgical methods and observe the med-term curative effect of primary repair and gastrocnemius turn-down flaps for acute Achilles tendon rupture, so as to guide clinical decision. Methods: This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, whose surgeries was completed by the sponsor with either primary repair or gastrocnemius turn-down flaps. The recovery and motor function of the patients were followed up by outpatient clinic and telephone at 3 months, 6 months, 12 months and 24 months after operation, respectively, so as to statistically analyze the med-term curative effects of two surgeries. Specific indicators include: Visual Analogue Scale, American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score, The Victorian Institute of Sport Assessment-Achilles, The Achilles tendon Total Rupture Score, the Tegner Activity Score, Biodex isokinetic dynamometer system, Postoperative rehabilitation index and complications.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary repair | – | –Patients with acute achilles tendon ruptures who received the treatment of primary repair. |
| gastrocnemius turn-down flaps | – | Procedure: gastrocnemius turn-down flapsPatients with acute achilles tendon ruptures who received the treatment of gastrocnemius turn-down flaps. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, including 68 male patients and 6 female patients. The average age is 36 years.
Key inclusion criteria (5 listed)
- history of Achilles tendon injury
- within two weeks of injury
- inability to single heel rise
- more than one year of follow-up
- age under 65
Key exclusion criteria (6 listed)
- open Achilles tendon rupture
- Achilles tendon terminal disease
- rerupture of Achilles tendon
- history of local corticosteroid injection around the Achilles tendon
- accompanied by fracture, vascular or nerve damage
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 |
|---|---|---|
| gastrocnemius turn-down flapsWe classified the patients with acute achilles tendon rupture by type of surgery. The group who received the gastrocnemius turn-down flaps is the intervention group. | Procedure or surgery | gastrocnemius turn-down flaps |
Primary outcome
change of Visual Analogue Scale
Time frame: from pre-surgery to two years after surgery
The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome.
change of American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
Time frame: from pre-surgery to two years after surgery
The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome.
change of The Victorian Institute of Sport Assessment-Achilles
Time frame: from pre-surgery to two years after surgery
The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score.
change of The Achilles tendon Total Rupture Score
Time frame: from pre-surgery to two years after surgery
The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score.
change of the Tegner Activity Score
Time frame: from pre-surgery to two years after surgery
The Tegner activity scale was first described in 1985 and initially designed for physician administration after ACL and meniscal injuries. To date, the Tegner activity score has been a frequently used patient-administered activity rating system for patients with various knee disorders. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Biodex
Time frame: through study completion, an average of 2 years
Biodex isokinetic dynamometer system
1 secondary outcome
complications
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Acute Rupture of Achilles Tendon (Disorder)
Not yet recruiting
Achilles Tendon Rupture - Intervention With Electrical Stimulation
Achilles Tendon Ruptures, Immobilization
Active, not recruiting
Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings
Achilles Tendon Rupture, Athletic Injuries
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.
Yingfang Ao, MD 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?
An observational study of Acute Rupture of Achilles Tendon (Disorder), 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 10 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Visual Analogue Scale (time frame: from pre-surgery to two years after surgery). The study lists 6 primary outcomes in all. 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 10 Jul 2020.