Haglund's DeformityNCT04471259
Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity
An observational study of Haglund's Deformity, run by Peking University Third Hospital at 1 site in China.
Trial summary
Isokinetic muscle strength test implemented by the Biodex system is a method used for evaluating muscle function that has been applied clinically in the field of sports and rehabilitation medicine. However, information on its application on Haglund's deformity remain insufficient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Haglund's Deformity
- What is being tested?
- Classification statistics
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2012to 21 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study included 42 cases of 37 patients diagnosed with Haglund disease treated by the author from 2012 to 2018 treated with endoscopic surgery (5 of whom were patients with left and right feet, 33 men, 4 women, average age 32.3 (range:15 to 62, SD=13.6) years, 2 of whom are professional athletes.
Who may be able to join
- Patients who underwent endoscopic surgery for Haglund's deformity
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Isokinetic muscle strength test implemented by the Biodex system is a method used for evaluating muscle function that has been applied clinically in the field of sports and rehabilitation medicine. However, information on its application on Haglund's deformity remain insufficient. Therefore, the present study is designed to examine the effectiveness of the muscle strength test using the Biodex system in evaluating the recovery of athletic capacity in patients with Haglund's deformity following endoscopic surgery.
Read the detailed description
Patients. A retrospective (medical records), level 3 evidence study was designed to evaluate the outcomes of patients who underwent endoscopic surgery for Haglund's deformity. The present study was approved by the Peking University Third Hospital's ethics committee. Written informed consent was obtained from all patients, parents or guardians of the patients prior to the present study. The rights of the patients were protected.
Diagnosis. Patients were designed to be diagnosed based on subjective complaints, combined with clinical and radiological examinations. Radiological measurements for this disease include the Fowler-Phillip angle, calcaneal pith angle, parallel pitch lines, Chauveaux-Liet angle and the X/Y ratio.
- Conditions
- Haglund's Deformity
- Being tested
- Classification statistics
- Keywords
- Haglund's Deformity, Biodex System, Isokinetic muscle testing, Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classification statisticsOther
We classified patients by gender, age, recovery time,etc
| Study group | Role | What they receive |
|---|---|---|
| Patients' injured side | The Biodex, AOFAS, VAS were tested on the patients' injured side Receives: Other: Classification statistics | |
| Patients' uninjured side | The Biodex, AOFAS, VAS were tested on the patients' uninjured side Receives: Other: Classification statistics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex results on both sides before surgery
Biodex isokinetic muscle testing system was applied in this research. Isokinetic muscle strength test is a kind of muscle function evaluation and test method, which has been applied in the research and clinical work of sports medicine and rehabilitation medicine but never on Haglund's disease before. The isokinetic muscle strength test of the flexor and dorsiflexion of the ankle joint can evaluate the muscle strength and endurance to reflect the postoperative patient's capacity for action, providing reliable clinical evidence for postoperative rehabilitation of patients after endoscopic calcaneoplasties. Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system before surgery.
Measured: pre-surgery
Biodex results on both sides at 3 months
Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 3 months after surgery.
Measured: 3 months after surgery
Biodex results on both sides at 6 months
Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 6 months after surgery.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start22 Jan 2012
- Primary completion22 Dec 2018
- Study completion21 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haglund's DeformityStudies 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
- 42 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
- NCT04471259
- Sponsor's protocol ID
- M2018151
- Status last verified
- Jul 2020
- First submitted
- 27 Jun 2020
- Last updated
- 15 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 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity
- ClinicalTrials.gov ID
- NCT04471259
- Acronym / sponsor ID
- M2018151
- Conditions
- Haglund's Deformity
- Keywords
- Haglund's Deformity, Biodex System, Isokinetic muscle testing, Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 22 Jan 2012 (actual)
- Primary completion
- 22 Dec 2018 (actual)
- Study completion
- 21 Mar 2020 (actual)
- First posted
- 15 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.
Isokinetic muscle strength test implemented by the Biodex system is a method used for evaluating muscle function that has been applied clinically in the field of sports and rehabilitation medicine. However, information on its application on Haglund's deformity remain insufficient. Therefore, the present study is designed to examine the effectiveness of the muscle strength test using the Biodex system in evaluating the recovery of athletic capacity in patients with Haglund's deformity following endoscopic surgery.
Detailed description
Patients. A retrospective (medical records), level 3 evidence study was designed to evaluate the outcomes of patients who underwent endoscopic surgery for Haglund's deformity. The present study was approved by the Peking University Third Hospital's ethics committee. Written informed consent was obtained from all patients, parents or guardians of the patients prior to the present study. The rights of the patients were protected.
Diagnosis. Patients were designed to be diagnosed based on subjective complaints, combined with clinical and radiological examinations. Radiological measurements for this disease include the Fowler-Phillip angle, calcaneal pith angle, parallel pitch lines, Chauveaux-Liet angle and the X/Y ratio.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients' injured side | – | Other: Classification statisticsThe Biodex, AOFAS, VAS were tested on the patients' injured side |
| Patients' uninjured side | – | Other: Classification statisticsThe Biodex, AOFAS, VAS were tested on the patients' uninjured side |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included 42 cases of 37 patients diagnosed with Haglund disease treated by the author from 2012 to 2018 treated with endoscopic surgery (5 of whom were patients with left and right feet, 33 men, 4 women, average age 32.3 (range:15 to 62, SD=13.6) years, 2 of whom are professional athletes.
Key inclusion criteria (1 listed)
- Patients who underwent endoscopic surgery for Haglund's deformity
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Classification statisticsWe classified patients by gender, age, recovery time,etc | Other | Patients' injured side, Patients' uninjured side |
Primary outcome
Biodex results on both sides before surgery
Time frame: pre-surgery
Biodex isokinetic muscle testing system was applied in this research. Isokinetic muscle strength test is a kind of muscle function evaluation and test method, which has been applied in the research and clinical work of sports medicine and rehabilitation medicine but never on Haglund's disease before. The isokinetic muscle strength test of the flexor and dorsiflexion of the ankle joint can evaluate the muscle strength and endurance to reflect the postoperative patient's capacity for action, providing reliable clinical evidence for postoperative rehabilitation of patients after endoscopic calcaneoplasties. Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system before surgery.
Biodex results on both sides at 3 months
Time frame: 3 months after surgery
Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 3 months after surgery.
Biodex results on both sides at 6 months
Time frame: 6 months after surgery
Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 6 months 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 15 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Haglund's Deformity
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
RecruitingObservational study
Zadek Osteotomy for Treatment of Haglund's Syndrome
Haglund's Disease
RecruitingObservational study
Embo Registry; National Registry for Artery Embolization
Chronic Pain, Osteoarthritis, Knee
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 Haglund's Deformity, 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 1 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 15 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?
Biodex results on both sides before surgery (time frame: pre-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 15 Jul 2020.