Avulsion Fracture of the Achilles TendonNCT04957069
Comparison of Surgical Outcomes Between Avulsion Fracture of the AT and Conventional ATR--a Retrospective Study
An observational study of Avulsion Fracture of the Achilles Tendon and Achilles Tendon Rupture, run by Peking University Third Hospital.
Trial summary
To compare the surgical outcomes between avulsion fracture of the Achilles tendon and conventional Achilles tendon rupture, collected and analysed information of patients preoperatively and postoperatively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Avulsion Fracture of the Achilles Tendon, Achilles Tendon Rupture
- What is being tested?
- fixation and primary repair
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Jun 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: From 2013 to 2017, patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture that underwent surgical treatment in our institute.
Who may be able to join
- patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture
Who cannot join
- neuromuscular related diseases
- other injuries of ankle joint
About this study
Official title: Comparison of Surgical Outcomes Between Avulsion Fracture of the Achilles Tendon and Conventional Achilles Tendon Rupture--a Retrospective Study
To compare the surgical outcomes between avulsion fracture of the Achilles tendon and conventional Achilles tendon rupture, collected and analysed information of patients preoperatively and postoperatively.
Read the detailed description
Include 30 patients with avulsion fracture of the Achilles tendon and 30 patients with Achilles tendon rupture underwent surgical treatment in our institute. Collect and evaluate MRI, VAS, AOFAS, and FFI score preoperatively and postoperatively. Finally explore the surgical outcomes between avulsion fracture of the AT and conventional ATR.
- Being tested
- fixation, primary repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixationProcedure or surgery
double row fixation with 3-4 wire anchors
primary repairProcedure or surgery
end-to-end repair
| Study group | Role | What they receive |
|---|---|---|
| Avulsion fracture | avulsion fracture of the Achilles tendon Receives: Procedure: fixation | |
| Rupture | Achilles tendon rupture Receives: Procedure: primary repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOCART
MOCART is a scoring system to evaluate the repair effect of cartilage injury.The minimum and maximum values of MOCART are 100 and 0, respectively. And higher scores mean a better outcome.
Measured: one year after sugery
Secondary outcomes (3)
VAS
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: pre-surgery, one year after sugery
AOFAS
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: pre-surgery, one year after sugery
FFI
A Foot Function Index (FFI) was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. The FFI was examined for test-retest reliability, internal consistency, and construct and criterion validity. Each scale is from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it required help) .
Measured: pre-surgery, one year after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Jan 2013
- Primary completion31 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avulsion Fracture of the Achilles TendonStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qinwei Guo, MD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957069
- Sponsor's protocol ID
- M2018040
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Outcomes Between Avulsion Fracture of the Achilles Tendon and Conventional Achilles Tendon Rupture--a Retrospective Study
- ClinicalTrials.gov ID
- NCT04957069
- Acronym / sponsor ID
- M2018040
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 12 Jul 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.
To compare the surgical outcomes between avulsion fracture of the Achilles tendon and conventional Achilles tendon rupture, collected and analysed information of patients preoperatively and postoperatively.
Detailed description
Include 30 patients with avulsion fracture of the Achilles tendon and 30 patients with Achilles tendon rupture underwent surgical treatment in our institute. Collect and evaluate MRI, VAS, AOFAS, and FFI score preoperatively and postoperatively. Finally explore the surgical outcomes between avulsion fracture of the AT and conventional ATR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avulsion fracture | – | Procedure: fixationavulsion fracture of the Achilles tendon |
| Rupture | – | Procedure: primary repairAchilles tendon rupture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From 2013 to 2017, patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture that underwent surgical treatment in our institute.
Key inclusion criteria (1 listed)
- patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture
Key exclusion criteria (2 listed)
- neuromuscular related diseases
- other injuries of ankle joint
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 |
|---|---|---|
| fixationdouble row fixation with 3-4 wire anchors | Procedure or surgery | Avulsion fracture |
| primary repairend-to-end repair | Procedure or surgery | Rupture |
Primary outcome
MOCART
Time frame: one year after sugery
MOCART is a scoring system to evaluate the repair effect of cartilage injury.The minimum and maximum values of MOCART are 100 and 0, respectively. And higher scores mean a better outcome.
3 secondary outcomes
VAS
Time frame: pre-surgery, one year after sugery
AOFAS
Time frame: pre-surgery, one year after sugery
FFI
Time frame: pre-surgery, one year after sugery
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 12 Jul 2021.
- Individual participant dataSharing planned: Undecided
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.
Qinwei Guo, MD study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Avulsion Fracture of the Achilles Tendon and Achilles Tendon Rupture, run by Peking University Third Hospital.
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 2 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 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
MOCART (time frame: one year after sugery). 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 12 Jul 2021.