Ankle SprainNCT07200271
Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments.
A study testing Arthroscopic reconstruction surgery and Open surgery in people with Ankle Sprain, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Arthroscopic reconstruction surgery and Open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- 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
Who cannot join
- History of previous ankle surgery
- Tibiotalar osteoarthritis or presence of chondral lesions on magnetic resonance imaging
- Active infections
- Contraindications for surgery
- Pregnancy
- Lactation
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- Known allergy to bovine collagen
- Autoimmune connective tissue disease
- Active oncological process
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Infanta Elena
Valdemoro, Madrid, 28342
Laura Conde Ruiz, MD, +34 695155570, laura.conde@quironsalud.es
Juan Chans Veres, MD-PhD, 678133294, juan.chans@quironsalud.es
About this study
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.
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.
Read more
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.
- Conditions
- Ankle Sprain
- Being tested
- Arthroscopic reconstruction surgery, Open surgery
- Keywords
- ALLOGRAFT, INSTABILITY, ANKLE, LIGAMENT
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic reconstruction surgeryProcedure or 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.
Open surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Open surgery arm | Active comparator | 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. Receives: Procedure: Open surgery |
| Arthroscopic surgery | Active comparator | Arthroscopic reconstruction with allograft is a surgery in which a tendon (generally from a tissue bank) is used to reconstruct the ligaments. This technique is performed through small incisions using arthroscopy Receives: Procedure: Arthroscopic reconstruction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: From surgery to the end of the follow up at 12 months after surgery
Secondary outcomes (4)
Determine whether there are differences in health outcomes
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).
Measured: From surgery to the end of the follow up at 12 months after surgery
Determine whether there are differences in patient-perceived pain
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: From surgery to the end of the follow up at 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized clinical trial with two parallel treatment arms, stratified by age and functional demand. One arm will undergo one of the reference surgical interventions for the treatment of chronic lateral ankle instability: the modified open Broström-Gould procedure. The other arm will undergo a more recently developed surgical intervention supported by studies with favorable outcomes: arthroscopic reconstruction of the anterior talofibular ligament and the calcaneofibular ligament.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Responsible party
- Principal investigator, Juan Chans Veres, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Investigators
- Juan Chans Veres, MD-PhD, Principal investigator, Hospital Universitario Infanta Elena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200271
- Sponsor's protocol ID
- INEST2025
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07200271
- Acronym / sponsor ID
- INEST2025
- Conditions
- Ankle Sprain
- Keywords
- ALLOGRAFT, INSTABILITY, ANKLE, LIGAMENT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Collaborators
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized clinical trial with two parallel treatment arms, stratified by age and functional demand. One arm will undergo one of the reference surgical interventions for the treatment of chronic lateral ankle instability: the modified open Broström-Gould procedure. The other arm will undergo a more recently developed surgical intervention supported by studies with favorable outcomes: arthroscopic reconstruction of the anterior talofibular ligament and the calcaneofibular ligament.
| Arm | Type | Receives |
|---|---|---|
| Open surgery arm | Active comparator | Procedure: Open surgeryOpen 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. |
| Arthroscopic surgery | Active comparator | Procedure: Arthroscopic reconstruction surgeryArthroscopic reconstruction with allograft is a surgery in which a tendon (generally from a tissue bank) is used to reconstruct the ligaments. This technique is performed through small incisions using arthroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
- BMI >30
Key exclusion criteria (9 listed)
- History of previous ankle surgery
- Tibiotalar osteoarthritis or presence of chondral lesions on magnetic resonance imaging
- Active infections
- Contraindications for surgery
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic reconstruction surgeryArthroscopic 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 or surgery | Arthroscopic surgery |
| Open surgeryOpen 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. | Procedure or surgery | Open surgery arm |
Primary outcome
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
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Chans Veres, MD-PhD principal investigator
Hospital Universitario Infanta Elena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic reconstruction surgery and Open surgery in people with Ankle Sprain, run by Universidad Francisco de Vitoria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Chans Veres, Md, PhD (+34 678133294, juan.chans@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.