Achilles Tendon RuptureNCT04962243
Whether Patients With Achilles Tendon Tears Have Different Lipid Levels Than Healthy People: a Retrospective Study
An observational study of Achilles Tendon Rupture, run by Peking University Third Hospital at 1 site in China.
Trial summary
To explore the difference of blood lipid levels between patients with Achilles tendon rupture and healthy people without Achilles tendon rupture, and to provide clues for further exploration of its mechanism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Repair surgery for Achilles tendon rupture
- Type of treatment
- Surgery or procedure
- How many people
- 10,662 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Mar 2019
- 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: Yang Yuping, Deputy Chief Physician of the Institute of Sports Medicine of Peking University Third Hospital from January 2017 to December 2017 in Peking University Third Hospital of Sports Medicine for patients with Achilles tendon rupture repair surgery
Who may be able to join
- Rupture of Achilles tendon repair surgery experience
Who cannot join
- hypertension
- diabetes
- Professional athlete
- No blood lipid test results
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Univerisity Third Hospital
Beijing, Beijing Municipality, 100191
About this study
To explore the difference of blood lipid levels between patients with Achilles tendon rupture and healthy people without Achilles tendon rupture, and to provide clues for further exploration of its mechanism.
Read the detailed description
Data were collected from 287 patients with Achilles tendon rupture repaired by Yang Yuping, deputy chief physician of the Institute of Sports Medicine of Peking University Third Hospital from January 2017 to December 2017. A total of 10,375 subjects who underwent physical examination in the Physical Examination Center of Peking University Third Hospital during the same period were selected as the control group, and 9,193 subjects were selected as the control group after excluding patients without blood lipid test results, professional athletes, hypertension and diabetes patients. The general data, blood glucose, blood lipid, blood uric acid, smoking and alcohol consumption of the subjects were collected through the hospital information system. The blood glucose, blood lipid, uric acid and other data of the control group and the Achilles tendon rupture group were detected, and it was concluded that the blood lipid level of the patients with Achilles tendon rupture group was higher than that of the control group.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Repair surgery for Achilles tendon rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair surgery for Achilles tendon ruptureProcedure or surgery
Repair surgery for Achilles tendon rupture
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing repair of Achilles tendon rupture | Patients undergoing repair of Achilles tendon rupture Receives: Procedure: Repair surgery for Achilles tendon rupture | |
| Subjects who underwent physical examination during the same period | Subjects who underwent physical examination in the Physical Examination Center of Peking University Third Hospital during the same period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose levels
Blood glucose levels of patients and control group were measured one month after surgery.
Measured: a month after the surgery
blood lipid levels
blood lipid levels of patients and control group were measured one month after surgery.
Measured: a month after the surgery
uric acid levels
uric acid levels of patients and control group were measured one month after surgery.
Measured: a month 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 posted14 Jul 2021
- Study start1 Jan 2019
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
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-control
- Time perspective
- Retrospective
- Enrolment
- 10,662 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
- NCT04962243
- Sponsor's protocol ID
- M2019127
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 14 Jul 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 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whether Patients With Achilles Tendon Tears Have Different Lipid Levels Than Healthy People: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04962243
- Acronym / sponsor ID
- M2019127
- Conditions
- Achilles Tendon Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,662 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 14 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 explore the difference of blood lipid levels between patients with Achilles tendon rupture and healthy people without Achilles tendon rupture, and to provide clues for further exploration of its mechanism.
Detailed description
Data were collected from 287 patients with Achilles tendon rupture repaired by Yang Yuping, deputy chief physician of the Institute of Sports Medicine of Peking University Third Hospital from January 2017 to December 2017. A total of 10,375 subjects who underwent physical examination in the Physical Examination Center of Peking University Third Hospital during the same period were selected as the control group, and 9,193 subjects were selected as the control group after excluding patients without blood lipid test results, professional athletes, hypertension and diabetes patients. The general data, blood glucose, blood lipid, blood uric acid, smoking and alcohol consumption of the subjects were collected through the hospital information system. The blood glucose, blood lipid, uric acid and other data of the control group and the Achilles tendon rupture group were detected, and it was concluded that the blood lipid level of the patients with Achilles tendon rupture group was higher than that of the control group.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing repair of Achilles tendon rupture | – | Procedure: Repair surgery for Achilles tendon rupturePatients undergoing repair of Achilles tendon rupture |
| Subjects who underwent physical examination during the same period | – | –Subjects who underwent physical examination in the Physical Examination Center of Peking University Third Hospital during the same period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Yang Yuping, Deputy Chief Physician of the Institute of Sports Medicine of Peking University Third Hospital from January 2017 to December 2017 in Peking University Third Hospital of Sports Medicine for patients with Achilles tendon rupture repair surgery
Key inclusion criteria (1 listed)
- Rupture of Achilles tendon repair surgery experience
Key exclusion criteria (4 listed)
- hypertension
- diabetes
- Professional athlete
- No blood lipid test results
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 |
|---|---|---|
| Repair surgery for Achilles tendon ruptureRepair surgery for Achilles tendon rupture | Procedure or surgery | Patients undergoing repair of Achilles tendon rupture |
Primary outcome
Blood glucose levels
Time frame: a month after the surgery
Blood glucose levels of patients and control group were measured one month after surgery.
blood lipid levels
Time frame: a month after the surgery
blood lipid levels of patients and control group were measured one month after surgery.
uric acid levels
Time frame: a month after the surgery
uric acid levels of patients and control group were measured one month after surgery.
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 14 Jul 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.
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, 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 4 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 14 Jul 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?
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?
Blood glucose levels (time frame: a month after the surgery). The study lists 3 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 14 Jul 2021.