Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments.

Not Applicable

Recruiting

• Conditions: Ankle Sprain

• Registration Number: NCT07200271
• Lead Sponsor: Universidad Francisco de Vitoria

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2027-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	From surgery to the end of the follow up at 12 months after surgery	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. For this purpose, the clinical AOFAS (American Orthopedics Foot and Ankle Score) score will be used. The minimum value for the AOFAS score is 0 and the maximum value is 100. Higher scores on the AOFAS scale indicate a better outcome, meaning less pain, better function, and improved alignment.

Secondary Outcome Measures

Name	Time	Method
Determine whether there are differences in health outcomes	From surgery to the end of the follow up at 12 months after surgery	Determine whether there are differences in health outcomes using the specific SP-36 (Short Form Health Survey) scale, is a 36-item questionnaire designed to measure health-related quality of life, it measures eight items: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health. The score goes from 0 (worst health status) to 100 (best health status).
Determine whether there are differences in patient-perceived pain	From surgery to the end of the follow up at 12 months after surgery	Determine whether there are differences in patient-perceived pain by using verbal numerical rating scale (VNRS). This score is widely used tool for assessing pain intensity, it measures pain from 0 (no pain) to 10 (worst paing imaginable).
Determine whether there are differences between both groups in the rate of postoperative complications.	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, defined as: Delay or absence of surgical wound healing, superficial infection, deep infection, recurrence or persistence of instability, sural nerve and superficial peroneal nerve neuropathy and complex regional pain syndrome. They are all qualitative variables. They will be expressed in the categories: yes or no.
Determine whether there are differences in time to return to normal life between the two surgical techniques.	From surgery to the end of the follow up at 12 months after surgery	Determine whether there are differences in the time to return to normal life between the two surgical techniques. To do this, we will compare both groups in terms of time expressed in days.

Trial Locations

Locations (1)

Hospital Universitario Infanta Elena; 🇪🇸 Valdemoro, Madrid, Spain