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| Name | Class |
|---|---|
| Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic reconstruction surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From surgery to the end of the follow up at 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Mandatory criteria (all must be marked "yes" in a drop-down tab):
Specific criteria (must meet at least one, but can meet several, multiple choice option):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Chans Veres, Md, PhD | Contact | +34 678133294 | juan.chans@quironsalud.es | |
| Laura Conde Ruiz, MD | Contact | +34 695155570 | laura.conde@quironsalud.es |
| Name | Affiliation | Role |
|---|---|---|
| Juan Chans Veres, MD-PhD | Hospital Universitario Infanta Elena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Infanta Elena | Recruiting | Valdemoro | Madrid | 28342 | Spain |
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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.
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| Open surgery | Procedure | 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. |
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| 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). | 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. | 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. | From surgery to the end of the follow up at 12 months after surgery |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D061887 | Conversion to Open Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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