Ankle FracturesNCT06086223
Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy
A study testing ankle arthroscopy with ORIF and fracture ankle fixation without ankle arthroscopy in people with Ankle Fractures and Ankle Injuries, run by Assiut University.
Trial summary
The aim of our study is to identify if there is statistically significant difference in patient reported functional outcomes in cases of unstable ankle fracture managed by ORIF with and without ankle arthroscopy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ankle Fractures, Ankle Injuries, Arthroscopic Surgery
- What is being tested?
- ankle arthroscopy with ORIF and fracture ankle fixation without ankle arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ≥16 years of age who will be managed operatively for:
- rotational ankle fracture Danis-Weber classification B or C fibula fracture
- fracture dislocation ankle
- Fractures extending into the tibial plafond,
- Talus fractures (body or neck) in our institution
Who cannot join
- Pediatric fractures, Polytrauma patients, Fractures managed with closed-contact casting and, patients with lost follow up during this study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy: Randomized Control Study
The aim of our study is to identify if there is statistically significant difference in patient reported functional outcomes in cases of unstable ankle fracture managed by ORIF with and without ankle arthroscopy.
Read the detailed description
Acute ankle fracture is one of the commonest fractures of the lower limb. Anatomical reduction and stable fixation remain the main surgical treatment for unstable ankle fractures . However, its final outcomes are not as good as expected . Fracture malunion, failure to address the disrupted syndesmosis and associated ligamentous or chondral lesions can be reasons for poor surgical outcome.
1-mm of lateral talar shift lead to a 42% increase in contact stress, so the anatomic reduction is critical to the long-term integrity of the joint . It is difficult to assess 1 to 2 mm of mal-reduction with C-arm fluoroscopy. The best assessment of the syndesmotic reduction is performed with axial CT imaging of the ankle.
Ankle arthroscopy is expected to be a more sensitive tool for syndesmotic disruption diagnosis and other intra-articular pathologies and as a guide for anatomical reduction of the syndesmosis . Several studies have reported the incidence of chondral lesions seen during ankle arthroscopy at the time of ankle fracture ORIF, but those studies report the role of arthroscopy as a diagnostic or predictive tool for patient outcome. Very few studies have discussed the rates of arthroscopic intervention, the procedures performed, and the association of these procedures with patient final functional outcomes .
- Conditions
- Ankle Fractures, Ankle Injuries, Arthroscopic Surgery
- Being tested
- ankle arthroscopy with ORIF, fracture ankle fixation without ankle arthroscopy
- Keywords
- functional outcomes of ankle fracture management, ankle scope, syndesmosis reduction, ankle ligaments evaluation
- Medical subject headings
- Ankle Fractures, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ankle arthroscopy with ORIFProcedure or surgery
Also called ankle fracture fixation with arthroscopy
we will go for fixation of the fracture with association of scope intervention pre and post fixation
fracture ankle fixation without ankle arthroscopyProcedure or surgery
Also called ankle fracture fixation without arthroscopy
we will go for fixation of the fracture alone with no scope intervention
| Study group | Role | What they receive |
|---|---|---|
| those patients who will go for ORIF plus arthroscopy | Experimental | we will start with a standard ankle arthroscopy. A leg holder and ankle joint distractor will be used. We will start with the anteromedial portal and introduce the 4-mm scope into the ankle joint. Next, under direct visualization, and taking care to preserve any branches of the superficial peroneal nerve, we will perform the anterolateral portal.
We will carry out a standard diagnostic ankle arthroscopy to evaluate the ankle cartilage, wash intra-articular haematoma, identify, and remove any intra-articular fracture fragments and loose bodies, perform dynamic ligamentous stress examinations while directly visualizing the syndesmosis, the deltoid ligament, and the lateral collateral ligament.
Following fracture fixation, arthroscopy will be also used as a second look to evaluate the quality of both articular and syndesmotic reduction, perform any needed arthroscopic intervention for deltoid ligament injury or management of chondral lesions (OCLs) Receives: Procedure: ankle arthroscopy with ORIF |
| patients who will go for ORIF without arthroscopy | Experimental | * Posterior malleolus fractures will be addressed when it is present whatever its size.
* The fibula fractures will be fixated using either a posterolateral or direct lateral incision. Lag screws will be used when the fracture pattern allows, and all fractures will be also treated with a neutralization or antiglide plate depending on the pattern and approach.
* If a medial malleolus fracture is present, this will be addressed through a direct medial incision. These fractures will be either fixed with cannulated screws or tension band cerclage wiring or a plate and screw construct depending on the fracture pattern.
* Once all bony injuries will be stabilized, a Cotton test will be performed under live fluoroscopy to determine syndesmosis stability. If positive, the syndesmosis will be stabilized using fully threaded screws. Receives: Procedure: fracture ankle fixation without ankle arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score
AOFAS hindfoot score difference between the 2 groups at 6 months and one year postoperatively from 0 to 100 where higher value indicates better functional outcomes
Measured: 6 months and one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Based on determining outcome variable, the estimated minimum required sample size is 176 cases (88 cases in each group). The sample size was calculated using G\*power software 3.1.9.7., based on the following assumptions: the patient satisfaction rate was higher in those patients who underwent arthroscopy compared with ORIF alone (93% vs 75%, P ¼ .05) (5). Main statistical test is z test, Alpha = 0.05, Power = 0.95 Allocation ratio= 1.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Taher Alaa Eldin Ahmed Eid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086223
- Sponsor's protocol ID
- Arthroscopy for ankle fracture
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith KS, Drexelius K, Challa S, Moon DK, Metzl JA, Hunt KJ. Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy. Foot Ankle Orthop. 2020 Mar 2;5(1):2473011420904046. doi: 10.1177/2473011420904046. eCollection 2020 Jan.
PubMed 35097364Zengerink M, Struijs PA, Tol JL, van Dijk CN. Treatment of osteochondral lesions of the talus: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2010 Feb;18(2):238-46. doi: 10.1007/s00167-009-0942-6. Epub 2009 Oct 27.
PubMed 19859695
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy: Randomized Control Study
- ClinicalTrials.gov ID
- NCT06086223
- Acronym / sponsor ID
- Arthroscopy for ankle fracture
- Conditions
- Ankle Fractures, Ankle Injuries, Arthroscopic Surgery
- Keywords
- functional outcomes of ankle fracture management, ankle scope, syndesmosis reduction, ankle ligaments evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 17 Oct 2023 (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.
The aim of our study is to identify if there is statistically significant difference in patient reported functional outcomes in cases of unstable ankle fracture managed by ORIF with and without ankle arthroscopy.
Detailed description
Acute ankle fracture is one of the commonest fractures of the lower limb. Anatomical reduction and stable fixation remain the main surgical treatment for unstable ankle fractures . However, its final outcomes are not as good as expected . Fracture malunion, failure to address the disrupted syndesmosis and associated ligamentous or chondral lesions can be reasons for poor surgical outcome.
1-mm of lateral talar shift lead to a 42% increase in contact stress, so the anatomic reduction is critical to the long-term integrity of the joint . It is difficult to assess 1 to 2 mm of mal-reduction with C-arm fluoroscopy. The best assessment of the syndesmotic reduction is performed with axial CT imaging of the ankle.
Ankle arthroscopy is expected to be a more sensitive tool for syndesmotic disruption diagnosis and other intra-articular pathologies and as a guide for anatomical reduction of the syndesmosis . Several studies have reported the incidence of chondral lesions seen during ankle arthroscopy at the time of ankle fracture ORIF, but those studies report the role of arthroscopy as a diagnostic or predictive tool for patient outcome. Very few studies have discussed the rates of arthroscopic intervention, the procedures performed, and the association of these procedures with patient final functional outcomes .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Based on determining outcome variable, the estimated minimum required sample size is 176 cases (88 cases in each group). The sample size was calculated using G*power software 3.1.9.7., based on the following assumptions: the patient satisfaction rate was higher in those patients who underwent arthroscopy compared with ORIF alone (93% vs 75%, P ¼ .05) (5). Main statistical test is z test, Alpha = 0.05, Power = 0.95 Allocation ratio= 1.
| Arm | Type | Receives |
|---|---|---|
| those patients who will go for ORIF plus arthroscopy | Experimental | Procedure: ankle arthroscopy with ORIFwe will start with a standard ankle arthroscopy. A leg holder and ankle joint distractor will be used. We will start with the anteromedial portal and introduce the 4-mm scope into the ankle joint. Next, under direct visualization, and taking care to preserve any branches of the superficial peroneal nerve, we will perform the anterolateral portal. We will carry out a standard diagnostic ankle arthroscopy to evaluate the ankle cartilage, wash intra-articular haematoma, identify, and remove any intra-articular fracture fragments and loose bodies, perform dynamic ligamentous stress examinations while directly visualizing the syndesmosis, the deltoid ligament, and the lateral collateral ligament. Following fracture fixation, arthroscopy will be also used as a second look to evaluate the quality of both articular and syndesmotic reduction, perform any needed arthroscopic intervention for deltoid ligament injury or management of chondral lesions (OCLs) |
| patients who will go for ORIF without arthroscopy | Experimental | Procedure: fracture ankle fixation without ankle arthroscopy* Posterior malleolus fractures will be addressed when it is present whatever its size. * The fibula fractures will be fixated using either a posterolateral or direct lateral incision. Lag screws will be used when the fracture pattern allows, and all fractures will be also treated with a neutralization or antiglide plate depending on the pattern and approach. * If a medial malleolus fracture is present, this will be addressed through a direct medial incision. These fractures will be either fixed with cannulated screws or tension band cerclage wiring or a plate and screw construct depending on the fracture pattern. * Once all bony injuries will be stabilized, a Cotton test will be performed under live fluoroscopy to determine syndesmosis stability. If positive, the syndesmosis will be stabilized using fully threaded screws. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥16 years of age who will be managed operatively for:
Key exclusion criteria (1 listed)
- Pediatric fractures, Polytrauma patients, Fractures managed with closed-contact casting and, patients with lost follow up during this study
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 |
|---|---|---|
| ankle arthroscopy with ORIFAlso: ankle fracture fixation with arthroscopywe will go for fixation of the fracture with association of scope intervention pre and post fixation | Procedure or surgery | those patients who will go for ORIF plus arthroscopy |
| fracture ankle fixation without ankle arthroscopyAlso: ankle fracture fixation without arthroscopywe will go for fixation of the fracture alone with no scope intervention | Procedure or surgery | patients who will go for ORIF without arthroscopy |
Primary outcome
American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score
Time frame: 6 months and one year follow up
AOFAS hindfoot score difference between the 2 groups at 6 months and one year postoperatively from 0 to 100 where higher value indicates better functional outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 35097364Smith KS, Drexelius K, Challa S, Moon DK, Metzl JA, Hunt KJ. Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy. Foot Ankle Orthop. 2020 Mar 2;5(1):2473011420904046. doi: 10.1177/2473011420904046. eCollection 2020 Jan.
- Background: PubMed 19859695Zengerink M, Struijs PA, Tol JL, van Dijk CN. Treatment of osteochondral lesions of the talus: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2010 Feb;18(2):238-46. doi: 10.1007/s00167-009-0942-6. Epub 2009 Oct 27.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing ankle arthroscopy with ORIF and fracture ankle fixation without ankle arthroscopy in people with Ankle Fractures and Ankle Injuries, run by Assiut University.
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 5 inclusion and 1 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 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 El-Taher Alaa Eldin Ahmed Eid, assisstant lecturer (01004859149, taheralaa92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score (time frame: 6 months and one year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06086223, which also lists 2 linked publications.
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 17 Oct 2023.