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

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ClinicalTrials.gov Identifier: NCT01056055
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : January 26, 2010
Sponsor:
Information provided by:
Chonbuk National University Hospital

Tracking Information
First Submitted Date January 25, 2010
First Posted Date January 26, 2010
Last Update Posted Date January 26, 2010
Study Start Date February 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 25, 2010)
Talar tilt and anterior talar translation were measured on anterior and varus stress radiographs. [ Time Frame: during a minimum period of 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes of the Modified-Brostrom Procedure Using Suture Anchor for Chronic Lateral Ankle Instability
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
Brief 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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Chronic Ankle Instability
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 25, 2010)
40
Original Actual Enrollment Same as current
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 44 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01056055
Other Study ID Numbers titanick25
ClinicalTrials ( Registry Identifier: ClinicalTrials )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Byung-Ki Cho, Chungbuk National University Hospital
Study Sponsor Chonbuk National University Hospital
Collaborators Not Provided
Investigators
Study Chair: Byung-Ki Cho, M.D. Chungbuk National University Hospital
PRS Account Chonbuk National University Hospital
Verification Date March 2007