Chronic Ankle InstabilityNCT01056055
Outcomes of the Modified-Brostrom Procedure Using Suture Anchor for Chronic Lateral Ankle Instability
An observational study of Chronic Ankle Instability, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This prospective, randomized study was conducted to compare the clinical outcomes of the modified Brostrom procedure using a suture anchor and bone tunnel for chronic lateral ankle instability. Read more about this study
- Who is it for?
- Ages 15 to 44 years
- Conditions the study is for
- Chronic Ankle Instability
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2007to Dec 2009
- 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 15 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Of patients who underwent the modified Brostrom procedure under the diagnosis of chronic lateral ankle instability, 40 patients (40 ankles) who could be followed during a minimum period of 2 years were enrolled in the current study. The current study included patients who complained of unilateral ankle joint instability.
Who may be able to join
- Patients who complained of subjective instability of the ankle joint in whom repeated sprain injuries for > 6 months and pain were confirmed
- Patients with marked ankle instability confirmed by the anterior drawer test as compared with the contralateral ankle joint and tenderness involving the lateral ligament of the ankle joint was confirmed on physical examination
- Patients with an talar tilt angle exceeding 10o or a discrepancy of > 5o as compared with the non-affected side on stress radiography
- Patients with an anterior talar translation exceeding 10 mm or a discrepancy > 3 mm as compared with the non-affected side.
Who cannot join
- Patients who concurrently had an ankle fracture or marked tendon damage were excluded from the current analysis.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 360-711
About this study
Official title: Outcomes of the Modified-Brostrom Procedure Using Suture Anchor for Chronic Lateral Ankle Instability - A Prospective, Randomized Comparison With the Bone Tunnel Technique
This prospective, randomized study was conducted to compare the clinical outcomes of the modified Brostrom procedure using a suture anchor and bone tunnel for chronic lateral ankle instability.
Read the detailed description
With With the increased number of participants in sports and leisure time activities, the incidence of ankle ligament injuries has been correspondingly increased. Various surgical methods have been reported for chronic ankle instability. Of these methods, the modified Brostrom procedure is currently used most frequently, and its excellent treatment outcomes have been reported. If there are any methods for obtaining a strong ligament fixation force which are both technically simple and safe, such methods would shorten the operative time and be helpful for surgeons with little experience in managing chronic ankle instability to obtain excellent treatment outcomes. In recent years, a procedure using a suture anchor, which is used for various types of ligament or tendon reconstructions, has been frequently performed. To date, however, few studies have reported clinical outcomes of suture anchor techniques and comparisons of clinical results between suture anchor techniques and other procedures. Given the above background, we prospectively compared the clinical outcomes between the bone tunnel and suture anchor techniques in the modified Brostrom procedure for chronic lateral ankle instability.
- Conditions
- Chronic Ankle Instability
- Keywords
- Ankle, Chronic lateral instability, Modified Brostrom procedure, Suture anchor, Bone tunnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suture anchor, Bone tunnel | Suture anchor group: patients who underwent the modified Brostrom procedure using suture anchor technique Bone tunnel group: patients who underwent the modified Brostrom procedure using bone tunnel technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical evaluation consisted of a VAS for pain, the Karlsson scale, and the Sefton grading system.
Measured: during a minimum period of 2 years
Secondary outcomes (1)
Talar tilt and anterior talar translation were measured on anterior and varus stress radiographs.
Measured: during a minimum period 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 posted26 Jan 2010 (estimated)
- Study startFeb 2007
- Primary completionDec 2007
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Byung-Ki Cho, M.D., Study chair, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056055
- Sponsor's protocol ID
- titanick25
- Other IDs
- ClinicalTrials
- Status last verified
- Mar 2007
- First submitted
- 25 Jan 2010
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of the Modified-Brostrom Procedure Using Suture Anchor for Chronic Lateral Ankle Instability - A Prospective, Randomized Comparison With the Bone Tunnel Technique
- ClinicalTrials.gov ID
- NCT01056055
- Acronym / sponsor ID
- titanick25
- Conditions
- Chronic Ankle Instability
- Keywords
- Ankle, Chronic lateral instability, Modified Brostrom procedure, Suture anchor, Bone tunnel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Jan 2010 (estimated)
- 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 prospective, randomized study was conducted to compare the clinical outcomes of the modified Brostrom procedure using a suture anchor and bone tunnel for chronic lateral ankle instability.
Detailed description
With With the increased number of participants in sports and leisure time activities, the incidence of ankle ligament injuries has been correspondingly increased. Various surgical methods have been reported for chronic ankle instability. Of these methods, the modified Brostrom procedure is currently used most frequently, and its excellent treatment outcomes have been reported. If there are any methods for obtaining a strong ligament fixation force which are both technically simple and safe, such methods would shorten the operative time and be helpful for surgeons with little experience in managing chronic ankle instability to obtain excellent treatment outcomes. In recent years, a procedure using a suture anchor, which is used for various types of ligament or tendon reconstructions, has been frequently performed. To date, however, few studies have reported clinical outcomes of suture anchor techniques and comparisons of clinical results between suture anchor techniques and other procedures. Given the above background, we prospectively compared the clinical outcomes between the bone tunnel and suture anchor techniques in the modified Brostrom procedure for chronic lateral ankle instability.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suture anchor, Bone tunnel | – | –Suture anchor group: patients who underwent the modified Brostrom procedure using suture anchor technique Bone tunnel group: patients who underwent the modified Brostrom procedure using bone tunnel technique |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Of patients who underwent the modified Brostrom procedure under the diagnosis of chronic lateral ankle instability, 40 patients (40 ankles) who could be followed during a minimum period of 2 years were enrolled in the current study. The current study included patients who complained of unilateral ankle joint instability.
Key inclusion criteria (4 listed)
- Patients who complained of subjective instability of the ankle joint in whom repeated sprain injuries for > 6 months and pain were confirmed
- Patients with marked ankle instability confirmed by the anterior drawer test as compared with the contralateral ankle joint and tenderness involving the lateral ligament of the ankle joint was confirmed on physical examination
- Patients with an talar tilt angle exceeding 10o or a discrepancy of > 5o as compared with the non-affected side on stress radiography
- Patients with an anterior talar translation exceeding 10 mm or a discrepancy > 3 mm as compared with the non-affected side.
Key exclusion criteria (1 listed)
- Patients who concurrently had an ankle fracture or marked tendon damage were excluded from the current analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The clinical evaluation consisted of a VAS for pain, the Karlsson scale, and the Sefton grading system.
Time frame: during a minimum period of 2 years
1 secondary outcome
Talar tilt and anterior talar translation were measured on anterior and varus stress radiographs.
Time frame: during a minimum period 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 26 Jan 2010.
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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.
Byung-Ki Cho, M.D. study chair
Chungbuk National University 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 Chronic Ankle Instability, run by Chonbuk National University Hospital at 1 site in South Korea.
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 4 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 26 Jan 2010. 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 South Korea. 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?
The clinical evaluation consisted of a VAS for pain, the Karlsson scale, and the Sefton grading system. (time frame: during a minimum period of 2 years). 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 26 Jan 2010.