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

This study has been completed.
Sponsor:
Information provided by:
Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01056055
First received: January 25, 2010
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition
Chronic Ankle Instability

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Talar tilt and anterior talar translation were measured on anterior and varus stress radiographs. [ Time Frame: during a minimum period of 2 years ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2007
Study Completion Date: December 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056055

Locations
Korea, Republic of
Chungbuk National University Hospital
Cheongju, ChungBuk, Korea, Republic of, 360-711
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Study Chair: Byung-Ki Cho, M.D. Chungbuk National University
  More Information

No publications provided

Responsible Party: Byung-Ki Cho, Chungbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01056055     History of Changes
Other Study ID Numbers: titanick25, ClinicalTrials
Study First Received: January 25, 2010
Last Updated: January 25, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Chonbuk National University Hospital:
Ankle
Chronic lateral instability
Modified Brostrom procedure
Suture anchor
Bone tunnel

ClinicalTrials.gov processed this record on November 20, 2014