Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arthroscopic reconstruction surgery, Open surgery.
- Who it may be relevant to
- Registry conditions: Ankle Sprain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments. A Randomized Stratified Clinical Trial.
Overview
Primary Objective: To clarify whether arthroscopic reconstruction with allograft provides tangible benefits over the modified open Broström-Gould technique, or if both are equivalent in efficacy and safety. The clinical AOFAS scale will be used for assessment. Secondary Objectives: To determine if there are differences in health outcomes and patient-perceived pain using the specific SP-36 scale and verbal numeric rating scale (VNRS). Additionally, to assess differences in postoperative complication rates and time to return to daily life activities between the two surgical techniques. Study Design: Prospective, randomized, controlled clinical trial with two parallel groups stratified by age and functional demand. Condition or Disorder Being Studied: Chronic lateral ankle instability. Study Population and Sample Size: The target population includes subjects diagnosed with chronic lateral ankle instability. The study population consists of patients diagnosed in the Orthopedics consultations at Hospital Infanta Elena who meet the inclusion and exclusion criteria. Based on sample size calculations, a total of 36 patients will be recruited. However, due to the prospective nature and stratification by epidemiological and functional variables, the sample size may be increased to ensure comparable groups in each stratum. Study Timeline and Estimated Completion Date: The study is expected to begin in the third quarter of 2025. Recruitment is estimated to last 24 months, with a follow-up period of 12 months, for a total duration of 3 years, ending in the third quarter of 2028.
Interventions
- Procedure Arthroscopic reconstruction surgery
Arthroscopic reconstruction with allograft, in which a tendon (generally from a tissue bank) is used to reconstruct the ligaments. This technique is performed through small incisions using arthroscopy. - Procedure Open surgery
Open surgery consists of the modified Broström-Gould technique, which allows for the reconstruction of damaged ligaments using the patient's own tissues through an incision on the lateral side of the fibula. This technique has shown satisfactory functional results.
Primary outcome measures
- Clarify whether arthroscopic reconstruction with allograft provides tangible benefits over the modified open Broström-Gould technique, or if both are equivalent in efficacy and safety. [Time frame: From surgery to the end of the follow up at 12 months after surgery]
Secondary outcome measures (4)
- Determine whether there are differences in health outcomes [Time frame: From surgery to the end of the follow up at 12 months after surgery]
- Determine whether there are differences in patient-perceived pain [Time frame: From surgery to the end of the follow up at 12 months after surgery]
- Determine whether there are differences between both groups in the rate of postoperative complications. [Time frame: From surgery to the end of the follow up at 12 months after surgery]
- Determine whether there are differences in time to return to normal life between the two surgical techniques. [Time frame: From surgery to the end of the follow up at 12 months after surgery]
Eligibility criteria
Inclusion criteria
Mandatory criteria (all must be marked "yes" in a drop-down tab):
- Age >18 years
- Subjective sensation of instability
- Pathological anterior drawer and varus tilt compared to the contralateral side
- Magnetic resonance imaging showing lesion of the anterior talofibular ligament (ATFL)
Specific criteria (must meet at least one, but can meet several, multiple choice option):
- BMI >30
- High athletic demand (regularly participates in pivoting sports)
- Ligamentous hyperlaxity (Beighton score >8)
- First sprain more than 2 years ago
- More than 5 sprains per year
- Subfibular ossicle >1 cm
- MRI with ATFL showing high T2 signal
- MRI showing disruption/absence of ATFL
Exclusion criteria
- History of previous ankle surgery
- Tibiotalar osteoarthritis or presence of chondral lesions on magnetic resonance imaging
- Active infections
- Contraindications for surgery
- Pregnancy
- Lactation
- Known allergy to bovine collagen
- Autoimmune connective tissue disease
- Active oncological process
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Universitario Infanta Elena — Valdemoro
Identifiers
NCT: NCT07200271 · INEST2025