- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01056055
Outcomes of the Modified-Brostrom Procedure Using Suture Anchor for Chronic Lateral Ankle Instability
January 25, 2010 updated by: Chonbuk National University Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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ChungBuk
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Cheongju, ChungBuk, Korea, Republic of, 360-711
- Chungbuk National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 44 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who concurrently had an ankle fracture or marked tendon damage were excluded from the current analysis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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during a minimum period of 2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Talar tilt and anterior talar translation were measured on anterior and varus stress radiographs.
Time Frame: during a minimum period of 2 years
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during a minimum period of 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Byung-Ki Cho, M.D., Chungbuk National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
January 25, 2010
First Submitted That Met QC Criteria
January 25, 2010
First Posted (Estimate)
January 26, 2010
Study Record Updates
Last Update Posted (Estimate)
January 26, 2010
Last Update Submitted That Met QC Criteria
January 25, 2010
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- titanick25
- ClinicalTrials (Registry Identifier: ClinicalTrials)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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