Clinical trial NCT01056055: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Ankle Instability
Keywords: Ankle
Chronic lateral instability
Modified Brostrom procedure
Suture anchor
Bone tunnel
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: The clinical evaluation consisted of a VAS for pain, the Karlsson scale, and the Sefton grading system.
timeFrame: during a minimum period of 2 years
Secondary outcomes:
measure: Talar tilt and anterior talar translation were measured on anterior and varus stress radiographs.
timeFrame: during a minimum period of 2 years
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: ChungBuk
Study officials:
affiliation: Chungbuk National University Hospital
name: Byung-Ki Cho, M.D.
role: STUDY_CHAIR
References: