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

Chronic Ankle Instability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056055
• Other study ID #: titanick25
• Secondary ID: ClinicalTrials
• Status: Completed
• Phase: N/A
• First received: January 25, 2010
• Last updated: January 25, 2010
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2007
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 44 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Ankle Instability

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju	ChungBuk

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinical evaluation consisted of a VAS for pain, the Karlsson scale, and the Sefton grading system.		during a minimum period of 2 years	No
Secondary	Talar tilt and anterior talar translation were measured on anterior and varus stress radiographs.		during a minimum period of 2 years	No