Outcomes of the Modified-Brostrom Procedure Using Suture Anchor for Chronic Lateral Ankle Instability

NCT ID: NCT01056055

Last Updated: 2010-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-12-31

Brief Summary

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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

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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

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Chronic Ankle Instability

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chungbuk National University Hospital

Principal Investigators

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Byung-Ki Cho, M.D.

Role: STUDY_CHAIR

Chungbuk National University Hospital

Locations

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Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ClinicalTrials

Identifier Type: REGISTRY

Identifier Source: secondary_id

titanick25

Identifier Type: -

Identifier Source: org_study_id

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