Ankle SprainsSTRONGNCT03472404
inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG
A study testing Internal Brace augmented ankle Ligament reconstruction and Brostrom-Gould ankle Ligament reconstruction in people with Ankle Sprains and Talofibular; Sprain (Strain), run by Walter van der Weegen at 3 sites in Netherlands.
Trial summary
This study evaluates the effect of internal bracing in lateral ligament ankle surgery. Half of the patients will receive the standard Brostrom-Gould reconstruction followed by a standard revalidation protocol including 6 weeks of immobilisation, while the other half of the patients will receive the same operation… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Ankle Sprains, Talofibular; Sprain (Strain)
- What is being tested?
- Internal Brace augmented ankle Ligament reconstruction and Brostrom-Gould ankle Ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Oct 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients 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 with isolated anterior talofibular ligament which is indicated for repair using the Brostrom-Gould technique.
- BMI ≤30
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- Patients who are able and willing to undergo ankle surgery.
- Patients who are able and willing to comply with the rehabilitation protocol in any of the study physiotherapy centers.
- Patients who are able and willing to return for follow-up evaluations.
- Patients with sufficient understanding of the Dutch language.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Gelre Ziekenhuis
Apeldoorn
Pieter Bullens, MD
- Recruiting
Medinova
Breda
Joost Schrier, MD, PhD
- Recruiting
St Anna hospital
Geldrop, 5664EH
Walter van der weegen, PhD
About this study
Official title: Lateral Ligament Repair for Ankle Instability Protected With Internal Bracing. A Multicenter, Randomized Controlled Trial.
This study evaluates the effect of internal bracing in lateral ligament ankle surgery. Half of the patients will receive the standard Brostrom-Gould reconstruction followed by a standard revalidation protocol including 6 weeks of immobilisation, while the other half of the patients will receive the same operation augmented with internal brace followed by an accelerated rehabilitation protocol.
Read the detailed description
Ankle inversion trauma often leads to chronic ankle instability which can severely limit the patient during daily activities, including work and sports. When conservative treatment fails, surgical treatment in which the ruptured anterior talofibular ligament (ATFL) is reconstructed can be considered. Surgical treatment for ankle instability is associated with a relatively long rehabilitation due to the initial limited strength of the reconstructed ligament. This limited strength in the first weeks after surgery makes it necessary to protect the reconstructed lateral ankle ligament with immobilization. Usually a lower leg plaster is applied for six weeks. Due to the initial limited strength of the reconstructed ligament and the immobilization period itself, return to activities after surgery for this injury usually takes up to six months or even more. Therefore, surgical intervention is only indicated for patients who suffer chronic, recurrent ankle instability.
With a new surgical technique, an internal brace is placed over the reconstructed lateral ankle ligament, thereby providing protection which makes immobilization in the postoperative weeks unnecessary. This allows an earlier start of the rehabilitation which might enhance ankle function postoperatively and allows earlier return to activities. Also, adding an internal brace to the reconstructed lateral ankle ligament might result in a lower recurrence rate of ankle instability compared to the current surgical procedure.
Objective: To evaluate if patients with chronic, recurrent lateral ankle instability who are treated with surgical lateral ankle ligament repair protected with an internal brace, have significant better ankle function after surgery compared to patients treated with standard surgical lateral ankle ligament reconstruction without internal brace. The appropriately adapted rehabilitation for each surgery procedure is applied.
- Conditions
- Ankle Sprains, Talofibular; Sprain (Strain)
- Being tested
- Internal Brace augmented ankle Ligament reconstruction, Brostrom-Gould ankle Ligament reconstruction
- Medical subject headings
- Ankle Injuries, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Brace augmented ankle Ligament reconstructionProcedure or surgery
internal brace augmented ankle ligament reconstruction and an accelerated revalidation protocol.
Brostrom-Gould ankle Ligament reconstructionProcedure or surgery
Brostrom-Gould and standard revalidation including 6 weeks immobilisation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Internal Brace augmented ankle Ligament reconstruction Receives: Procedure: Internal Brace augmented ankle Ligament reconstruction |
| Control Group | Active comparator | Brostrom-Gould ankle Ligament reconstruction Receives: Procedure: Brostrom-Gould ankle Ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Foot Ankle Outcome Score (FAOS) at 12 months
Patient reported outcome measure, consists of 42 items, each item is scored in a 5-point likert scale
Measured: pre-operative, post-operative at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies 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
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter van der Weegen
- Sponsor type
- University, hospital or other
- Collaborators
- Medinova Clinics, Gelre Hospitals
- Responsible party
- Sponsor-investigator, Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands
- Investigators
- Walter van der Weegen, Dr., Principal investigator, St. Anna Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472404
- Sponsor's protocol ID
- W18.016
- Acronym
- STRONG
- Status last verified
- Jun 2023
- First submitted
- 2 Mar 2018
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Ligament Repair for Ankle Instability Protected With Internal Bracing. A Multicenter, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03472404
- Acronym / sponsor ID
- STRONG / W18.016
- Conditions
- Ankle Sprains, Talofibular; Sprain (Strain)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Walter van der WeegenUniversity, hospital or other
- Collaborators
- Medinova Clinics, Gelre Hospitals
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Mar 2018 (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.
This study evaluates the effect of internal bracing in lateral ligament ankle surgery. Half of the patients will receive the standard Brostrom-Gould reconstruction followed by a standard revalidation protocol including 6 weeks of immobilisation, while the other half of the patients will receive the same operation augmented with internal brace followed by an accelerated rehabilitation protocol.
Detailed description
Ankle inversion trauma often leads to chronic ankle instability which can severely limit the patient during daily activities, including work and sports. When conservative treatment fails, surgical treatment in which the ruptured anterior talofibular ligament (ATFL) is reconstructed can be considered. Surgical treatment for ankle instability is associated with a relatively long rehabilitation due to the initial limited strength of the reconstructed ligament. This limited strength in the first weeks after surgery makes it necessary to protect the reconstructed lateral ankle ligament with immobilization. Usually a lower leg plaster is applied for six weeks. Due to the initial limited strength of the reconstructed ligament and the immobilization period itself, return to activities after surgery for this injury usually takes up to six months or even more. Therefore, surgical intervention is only indicated for patients who suffer chronic, recurrent ankle instability.
With a new surgical technique, an internal brace is placed over the reconstructed lateral ankle ligament, thereby providing protection which makes immobilization in the postoperative weeks unnecessary. This allows an earlier start of the rehabilitation which might enhance ankle function postoperatively and allows earlier return to activities. Also, adding an internal brace to the reconstructed lateral ankle ligament might result in a lower recurrence rate of ankle instability compared to the current surgical procedure.
Objective: To evaluate if patients with chronic, recurrent lateral ankle instability who are treated with surgical lateral ankle ligament repair protected with an internal brace, have significant better ankle function after surgery compared to patients treated with standard surgical lateral ankle ligament reconstruction without internal brace. The appropriately adapted rehabilitation for each surgery procedure is applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Internal Brace augmented ankle Ligament reconstructionInternal Brace augmented ankle Ligament reconstruction |
| Control Group | Active comparator | Procedure: Brostrom-Gould ankle Ligament reconstructionBrostrom-Gould ankle Ligament reconstruction |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- patients 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 with isolated anterior talofibular ligament which is indicated for repair using the Brostrom-Gould technique.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Internal Brace augmented ankle Ligament reconstructioninternal brace augmented ankle ligament reconstruction and an accelerated revalidation protocol. | Procedure or surgery | Intervention Group |
| Brostrom-Gould ankle Ligament reconstructionBrostrom-Gould and standard revalidation including 6 weeks immobilisation. | Procedure or surgery | Control Group |
Primary outcome
Change from baseline Foot Ankle Outcome Score (FAOS) at 12 months
Time frame: pre-operative, post-operative at 12 months
Patient reported outcome measure, consists of 42 items, each item is scored in a 5-point likert scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Walter van der Weegen, Dr. principal investigator
St. Anna Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Brace augmented ankle Ligament reconstruction and Brostrom-Gould ankle Ligament reconstruction in people with Ankle Sprains and Talofibular; Sprain (Strain), run by Walter van der Weegen at 3 sites in Netherlands.
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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walter van der Weegen, Dr. (+31 (0) 40 2864 280, w.vander.weegen@st-anna.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Foot Ankle Outcome Score (FAOS) at 12 months (time frame: pre-operative, post-operative at 12 months). 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 5 Jun 2023.