Skip to content

Lateral ligament repair for ankle instability protected with internal bracing. A multicenter, randomized controlled trial.

Lateral ligament repair for ankle instability protected with internal bracing. A multicenter, randomized controlled trial. - the STRONG-study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54817
Enrollment
42
Registered
2018-06-13
Start date
2018-12-04
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ankle instablity ankle sprain

Interventions

The Intervention Group (IG) has surgery to reconstruct the anterior talofibular ligament with an internal brace placed over the reconstructed ligament in the same surgical session. After surgery pat

Sponsors

Sint Annaziekenhuis
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Male or female patient diagnosed with chronic lateral ankle instability (multiple ankle inversion trauma within 12 months and symptoms present >1 year). Lateral ankle instability is present if the patient complains of giving way of the ankle and has positive signs of ankle instability during physical exam (talar tilt score of >15 degrees compared to contralateral ankle or anterior drawer test score of >10mm compared to the contralateral ankle. - Conservative therapy has failed. - Normal foot and ankle anatomy as determined by orthopedic surgeon. - Patients in whom their ankle symptoms interfere with their physical activities. - Patients between the age of 18 and 60 years. - Patients with isolated anterior talofibular ligament which is indicated for repair using the Brostrom-Gould technique. - BMI

Exclusion criteria

Exclusion criteria: - Patients who need concomitant ankle surgery (i.e. Calcaneofibular ligament reconstruction, peroneus tendon repair, arthroscopy of the ankle, etc). - Patients with comorbidities, including musculoskeletal injuries or diseases in other joints than the affected ankle which limits their physical activity. - Ankle instability due to abnormal foot and ankle anatomy. - No objective or subjective ankle instability. - Previous ankle surgery. - Patients in which the contralateral ankle also shows lateral ankle instability.

Design outcomes

Primary

MeasureTime frame
The difference in FAOS score three months after surgery between the Intervention Group and the Control Group is the main study endpoint.

Secondary

MeasureTime frame
Secondary endpoints are the incidence of recurrent ankle inversion trauma within one year after surgery and differences in subjective and objective ankle stability, motor control, pain, ankle function and satisfaction with the treatment between the IG and the CG. This will be determined by means of questionnaires, physical examination and clinimetric testing.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)