Achilles Tendon RuptureNCT04478383
Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique
An observational study of Achilles Tendon Rupture and Fracture, Avulsion, run by Peking University Third Hospital at 1 site in China.
Trial summary
This retrospective study identified 12 patients with Achilles sleeve avulsion from November 2013 to March 2016, aiming to explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Achilles Tendon Rupture, Fracture, Avulsion
- What is being tested?
- a new transosseous suture technique
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: One patient was lost to follow-up because she could not be contacted, having moved out of the country. The remaining 11 patients (10 men and one woman, average age: 46 years) were reviewed with an average follow-up time of 40 months (30-57 months).
Who may be able to join
- clinical presentations and physical examination, routine ankle X ray and MRI
Who cannot join
- calcaneal tuberosity avulsion fractures
- Achilles tendon rerupture
- previous surgical procedure on the affected Achilles tendon
Trial locations and contacts
1 site in 1 country.
About this study
This retrospective study identified 12 patients with Achilles sleeve avulsion from November 2013 to March 2016, aiming to explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.
Read the detailed description
Purpose: To explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.
Methods:In total, 11 patients diagnosed with Achilles sleeve avulsion underwent this new surgical technique and were followed for a mean time of 40 months. Clinical outcomes were measured using the visual analog scale (VAS), American Orthopaedic Foot \& Ankle Society (AOFAS) score, Victorian Institute of Sports Assessment-Achilles (VISA-A) score, Tegner score, and time taken to return to activities. Preoperative and postoperative MRI, the ability to perform heel rise, and complications were also evaluated.
- Conditions
- Achilles Tendon Rupture, Fracture, Avulsion
- Being tested
- a new transosseous suture technique
- Keywords
- Sleeve Avulsion, Achilles Tendinopathy, Suture, transosseous, Achilles Tendon
- Medical subject headings
- Fractures, Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a new transosseous suture techniqueProcedure or surgery
a new technique using the spur base on the insertional site to drill the suture tunnel to repair Achilles sleeve avulsion.
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Victorian Institute of Sports Assessment-Achilles 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 visual analog 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 & Ankle Society 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 Tegner 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Aug 2017
- Primary completion1 Feb 2018
- Study completion1 May 2018
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478383
- Sponsor's protocol ID
- M2018008
- Status last verified
- Jul 2020
- First submitted
- 27 Jun 2020
- Last updated
- 20 Jul 2020
- 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 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique
- ClinicalTrials.gov ID
- NCT04478383
- Acronym / sponsor ID
- M2018008
- Conditions
- Achilles Tendon Rupture, Fracture, Avulsion
- Keywords
- Sleeve Avulsion, Achilles Tendinopathy, Suture, transosseous, Achilles Tendon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 20 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 identified 12 patients with Achilles sleeve avulsion from November 2013 to March 2016, aiming to explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.
Detailed description
Purpose: To explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.
Methods:In total, 11 patients diagnosed with Achilles sleeve avulsion underwent this new surgical technique and were followed for a mean time of 40 months. Clinical outcomes were measured using the visual analog scale (VAS), American Orthopaedic Foot \& Ankle Society (AOFAS) score, Victorian Institute of Sports Assessment-Achilles (VISA-A) score, Tegner score, and time taken to return to activities. Preoperative and postoperative MRI, the ability to perform heel rise, and complications were also evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- One patient was lost to follow-up because she could not be contacted, having moved out of the country. The remaining 11 patients (10 men and one woman, average age: 46 years) were reviewed with an average follow-up time of 40 months (30-57 months).
Key inclusion criteria (1 listed)
- clinical presentations and physical examination, routine ankle X ray and MRI
Key exclusion criteria (3 listed)
- calcaneal tuberosity avulsion fractures
- Achilles tendon rerupture
- previous surgical procedure on the affected Achilles tendon
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 |
|---|---|---|
| a new transosseous suture techniquea new technique using the spur base on the insertional site to drill the suture tunnel to repair Achilles sleeve avulsion. | Procedure or surgery | – |
Primary outcome
change of Victorian Institute of Sports Assessment-Achilles 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 visual analog 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 & Ankle Society 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 Tegner 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.
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 20 Jul 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Achilles Tendon Rupture and Fracture, Avulsion, 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 1 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: finished, as of the sponsor's last update on 20 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 Victorian Institute of Sports Assessment-Achilles score (time frame: from pre-surgery to two years after surgery). The study lists 4 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 20 Jul 2020.