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Completed

NCT Number: NCT01056055

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

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.

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Key information

Age range

15 year–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 360-711, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Talar tilt and anterior talar translation were measured on anterior and varus stress radiographs.

    Time frame: during a minimum period of 2 years

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

Outcomes of the Modified-Brostrom Procedure Using Suture Anchor for Chronic Lateral Ankle Instability - A Prospective, Randomized Comparison With the Bone Tunnel Technique

Important dates

Study start
2007
Primary completion
2007
Study completion
2009
First posted
Jan 26, 2010
Registry last updated
Jan 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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