Ankle FracturesNCT06085586
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
A study testing Early Weight Bearing and Normal Weight Bearing in people with Ankle Fractures and Bimalleolar Fractures, run by Maimonides Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is critical due the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 Malreduction and instability of the distal… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Fractures, Bimalleolar Fractures, Syndesmotic Injuries
- What is being tested?
- Early Weight Bearing and Normal Weight Bearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2023to 31 Dec 2026
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ankle fracture with syndesmotic disruption as assessed with intra-operative cotton test.
- This includes the following injuries:
- Syndesmotic sprain (without fractures)
- Bimalleolar equivalent ankle fractures
- Bimalleolar ankle fractures
- Maisonneuve fractures
- Trimalleolar ankle fractures without the need for posterior malleolus fixation
- Ankle fracture dislocations
Who cannot join
- 1) previous ankle surgery, 2) active local infection about the ankle, 3) chronic ankle deformity secondary to trauma or congenital, 4) ligamentous laxity, 5) pathologic fractures, 6) peripheral vascular disease, 7) peripheral neuropathy, 8) diabetes neuropathy and charcot, 9) open fractures, 10) poly trauma, 11) inability to provide informed consent, 12) symptomatic ankle osteoarthritis, 12) retained hardware, 13) pregnant, 14) metabolic bone disease, 15) history of chronic steroid use, 16) mal-reduced ankle fractures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219
Antonios Likourezos, 718-283-6896, alikourezos@maimonidesmed.org
Amr A Abdelgawad, MD PhD MBA
About this study
Official title: Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is critical due the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 Malreduction and instability of the distal tibiotalar joint can lead to chronic instability, increased articular damage and ultimately degenerative arthritis.7,8 Medial to lateral translation of distal tibia and fibula of 2 mm or more has been considered pathologic.9 Earlier biomechanical study demonstrated the Fibulink system is superior in maintaining displacement of less than 2 mm.4 Given the improved strength, we also look to evaluate the outcomes of initiating full weight bearing (100%) with Controlled Ankle Motion (CAM) boot at 4 weeks postoperatively. One of the big limitations for trans-osseous screw fixation is delayed weight bearing due to risk of screw breakage.1 Suture button technique allowed for early weight bearing with average of 6 weeks postoperatively using TightRope.2,10-12By initiating full weight bearing (100%) with CAM boot at 4 weeks postoperatively, this would be a significant improvement in current clinical practice.
Read the detailed description
All ankle fractures will be evaluated by the orthopedic team. Standard radiographs including anteroposterior (AP), lateral and mortise view of the ankle will be obtained. Manual or gravity stress view will be performed if needed. Treatment options including nonoperative and operative management will be discussed with the patient including the risks and benefits. An informed decision will be made. Two separate informed consent will be obtained. The first will be an informed consent for the surgery, detailing the planned surgical procedure. The second will be an informed consent for the enrollment of the study, detailing the purpose of the study and the use of the Fibulink Syndesmotic Repair System in any cases of syndesmotic injury.
Should the patient elects to proceed with surgery, the patient will be informed that fixation of the fractures will be performed first. Direct lateral approach to the distal fibular will be used for fixation of the lateral malleolus. If necessary, direct medial approach will be used for fixation of the medial malleolus. Once the fractures have been fixed, the syndesmosis will be stressed intraoperatively under live fluoroscopy. Based on the parameters described in 6.3, a decision will be made whether fixation of the syndesmosis is required if instability is noted. If fixation of the syndesmosis is required, it will be performed through the direct lateral approach.
The research coordinator will be informed of all patients that had the syndesmosis fixed with the Fibulink System. Patients will then be followed at the following time points: 2 weeks, 4-6 weeks, 8-10 weeks, 3 months and 6 months. During each follow-up time points, the tibiofibular overlap, tibiofibular clear space and medial clear space will be measured and recorded. The postoperative protocol will be as follow: Immediately post-op, patient will be placed in a short leg cast. At 2 weeks postop, the short leg cast will be removed. Suture removal will be performed. Patient will be placed in a CAM boot and instructed to perform early active ankle range-of-motion. Depending on the study group, at 4 weeks or 6 weeks postop, full weight bearing (100%) in the CAM boot will be allowed. Physical therapy will begin. At 8-10 weeks postop, full weight bearing (100%) without CAM boot will begin. Patients will continue to follow-up at 3 months and 6 months.
The research coordinator will ensure proper follow-up and will be responsible for data collection and input. After achieving the planned number of participants, the results of the two study sites will be gathered. Appropriate statistical analysis will be performed, and the results will be presented in a full manuscript format.
- Conditions
- Ankle Fractures, Bimalleolar Fractures, Syndesmotic Injuries, Bimalleolar Equivalent Fracture, Maisonneuve Fracture, Trimalleolar Fractures
- Being tested
- Early Weight Bearing, Normal Weight Bearing
- Keywords
- Ankle Fractures, Bimalleolar Fractures, Bimalleolar Equivalent Fracture, Trimalleolar Fractures, Maisonneuve Fractures, Syndesmotic Injuries, Ankle Dislocations
- Medical subject headings
- Ankle Fractures, Ankle Injuries, Fibula Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Weight BearingOther
Full weight bearing (100%) initiated at 4 weeks postoperatively
Normal Weight BearingOther
Full weight bearing (100%) initiated at 6 weeks postoperatively
| Study group | Role | What they receive |
|---|---|---|
| 1) Early Full Weight Bearing | Experimental | Full weight bearing (100%) initiated at 4 weeks postoperatively Receives: Other: Early Weight Bearing |
| 2) Normal Full Weight Bearing | Active comparator | Full weight bearing (100%) initiated at 6 weeks postoperatively Receives: Other: Normal Weight Bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Reduction Quality
The primary objective is to evaluate the reduction and maintenance of the reduction of ankle syndesmosis in 6 months after initiating full weight bearing (100%) at 4 weeks or 6 weeks postoperatively. This will be determined based on comparing the tibiofibular overlap, tibiofibular clear space and medial clear space preoperative values.
Measured: 6 Months
Secondary outcomes (10)
2 Week Reduction Quality
Reduction and maintenance of the reduction of the ankle syndesmosis at 2 weeks based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
Measured: 2 Weeks
4-6 Week Reduction Quality
Reduction and maintenance of the reduction of the ankle syndesmosis at 4-6 weeks based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
Measured: 4-6 Weeks
8-10 Week Reduction Quality
Reduction and maintenance of the reduction of the ankle syndesmosis at 8-10 weeks based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
Measured: 8-10 Weeks
3 Month Reduction Quality
Reduction and maintenance of the reduction of the ankle syndesmosis at 3 months based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
Measured: 3 Months
Reoperation or Revision
Unplanned Reoperation or late-stage revision
Measured: 6 Months
OR Time
Operating Room Time in Minutes
Measured: 1 Day
Surgical Approach/Procedure Type
Surgical Approach/Procedure Type
Measured: 1 Day
Type of Additional Fixation
Type of Additional Fixation
Measured: 1 Day
Intraoperative Complications
Any complications that occurred intraoperatively
Measured: 1 Day
Postoperative Complications
Any complications that occurred postoperatively within 30 Days
Measured: 30 Days
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 start13 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Amr A Abdelgawad, MD PhD MBA, Principal investigator, Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085586
- Sponsor's protocol ID
- 2022-08-15-MMC
- Status last verified
- Mar 2026
- First submitted
- 10 Oct 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thornes B, Shannon F, Guiney AM, Hession P, Masterson E. Suture-button syndesmosis fixation: accelerated rehabilitation and improved outcomes. Clin Orthop Relat Res. 2005 Feb;(431):207-12.
PubMed 15685077Degroot H, Al-Omari AA, El Ghazaly SA. Outcomes of suture button repair of the distal tibiofibular syndesmosis. Foot Ankle Int. 2011 Mar;32(3):250-6. doi: 10.3113/FAI.2011.0250.
PubMed 21477543Morellato J, Louati H, Bodrogi A, Stewart A, Papp S, Liew A, Gofton W. The Effect of Varying Tension of a Suture Button Construct in Fixation of the Tibiofibular Syndesmosis-Evaluation Using Stress Computed Tomography. J Orthop Trauma. 2017 Feb;31(2):103-110. doi: 10.1097/BOT.0000000000000737.
PubMed 28129269Dynamic and Load-to-Failure Testing of the DePuy Synthes FIBULINK TM Syndesmosis Repair System and Arthrex Syndesmosis TightRope ® XP Implant System Materials and Methods. 2020.
Desai S. Syndesmosis Repair: 14 Patient Case Series.
Ramsey PL, Hamilton W. Changes in tibiotalar area of contact caused by lateral talar shift. J Bone Joint Surg Am. 1976 Apr;58(3):356-7.
PubMed 1262367Hunt KJ, Goeb Y, Behn AW, Criswell B, Chou L. Ankle Joint Contact Loads and Displacement With Progressive Syndesmotic Injury. Foot Ankle Int. 2015 Sep;36(9):1095-103. doi: 10.1177/1071100715583456. Epub 2015 May 6.
PubMed 25948693Porter DA, Jaggers RR, Barnes AF, Rund AM. Optimal management of ankle syndesmosis injuries. Open Access J Sports Med. 2014 Aug 5;5:173-82. doi: 10.2147/OAJSM.S41564. eCollection 2014.
PubMed 25177153Hunt KJ. Syndesmosis injuries. Curr Rev Musculoskelet Med. 2013 Dec;6(4):304-12. doi: 10.1007/s12178-013-9184-9.
PubMed 23949902Cottom JM, Hyer CF, Philbin TM, Berlet GC. Transosseous fixation of the distal tibiofibular syndesmosis: comparison of an interosseous suture and endobutton to traditional screw fixation in 50 cases. J Foot Ankle Surg. 2009 Nov-Dec;48(6):620-30. doi: 10.1053/j.jfas.2009.07.013. Epub 2009 Sep 15.
PubMed 19857816Thornes, Brian FRCSI; McCartan, Damien MB. Ankle Syndesmosis Injuries Treated with the TightRopeTM Suture-Button Kit. Techniques in Foot & Ankle Surgery 5(1):p 45-53, March 2006.
Latham AJ, Goodwin PC, Stirling B, Budgen A. Ankle syndesmosis repair and rehabilitation in professional rugby league players: a case series report. BMJ Open Sport Exerc Med. 2017 Apr 1;3(1):e000175. doi: 10.1136/bmjsem-2016-000175. eCollection 2017.
PubMed 28761696Cotton FJ. Dislocations and Joint-Fractures. Philadelphia: W. B. Saunders Company, 1910.
Ebraheim NA, Lu J, Yang H, Mekhail AO, Yeasting RA. Radiographic and CT evaluation of tibiofibular syndesmotic diastasis: a cadaver study. Foot Ankle Int. 1997 Nov;18(11):693-8. doi: 10.1177/107110079701801103.
PubMed 9391813Harper MC, Keller TS. A radiographic evaluation of the tibiofibular syndesmosis. Foot Ankle. 1989 Dec;10(3):156-60. doi: 10.1177/107110078901000308.
PubMed 2613128
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
- ClinicalTrials.gov ID
- NCT06085586
- Acronym / sponsor ID
- 2022-08-15-MMC
- Conditions
- Ankle Fractures, Bimalleolar Fractures, Syndesmotic Injuries, Bimalleolar Equivalent Fracture, Maisonneuve Fracture, Trimalleolar Fractures
- Keywords
- Ankle Fractures, Bimalleolar Fractures, Bimalleolar Equivalent Fracture, Trimalleolar Fractures, Maisonneuve Fractures, Syndesmotic Injuries, Ankle Dislocations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 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 purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is critical due the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 Malreduction and instability of the distal tibiotalar joint can lead to chronic instability, increased articular damage and ultimately degenerative arthritis.7,8 Medial to lateral translation of distal tibia and fibula of 2 mm or more has been considered pathologic.9 Earlier biomechanical study demonstrated the Fibulink system is superior in maintaining displacement of less than 2 mm.4 Given the improved strength, we also look to evaluate the outcomes of initiating full weight bearing (100%) with Controlled Ankle Motion (CAM) boot at 4 weeks postoperatively. One of the big limitations for trans-osseous screw fixation is delayed weight bearing due to risk of screw breakage.1 Suture button technique allowed for early weight bearing with average of 6 weeks postoperatively using TightRope.2,10-12By initiating full weight bearing (100%) with CAM boot at 4 weeks postoperatively, this would be a significant improvement in current clinical practice.
Detailed description
All ankle fractures will be evaluated by the orthopedic team. Standard radiographs including anteroposterior (AP), lateral and mortise view of the ankle will be obtained. Manual or gravity stress view will be performed if needed. Treatment options including nonoperative and operative management will be discussed with the patient including the risks and benefits. An informed decision will be made. Two separate informed consent will be obtained. The first will be an informed consent for the surgery, detailing the planned surgical procedure. The second will be an informed consent for the enrollment of the study, detailing the purpose of the study and the use of the Fibulink Syndesmotic Repair System in any cases of syndesmotic injury.
Should the patient elects to proceed with surgery, the patient will be informed that fixation of the fractures will be performed first. Direct lateral approach to the distal fibular will be used for fixation of the lateral malleolus. If necessary, direct medial approach will be used for fixation of the medial malleolus. Once the fractures have been fixed, the syndesmosis will be stressed intraoperatively under live fluoroscopy. Based on the parameters described in 6.3, a decision will be made whether fixation of the syndesmosis is required if instability is noted. If fixation of the syndesmosis is required, it will be performed through the direct lateral approach.
The research coordinator will be informed of all patients that had the syndesmosis fixed with the Fibulink System. Patients will then be followed at the following time points: 2 weeks, 4-6 weeks, 8-10 weeks, 3 months and 6 months. During each follow-up time points, the tibiofibular overlap, tibiofibular clear space and medial clear space will be measured and recorded. The postoperative protocol will be as follow: Immediately post-op, patient will be placed in a short leg cast. At 2 weeks postop, the short leg cast will be removed. Suture removal will be performed. Patient will be placed in a CAM boot and instructed to perform early active ankle range-of-motion. Depending on the study group, at 4 weeks or 6 weeks postop, full weight bearing (100%) in the CAM boot will be allowed. Physical therapy will begin. At 8-10 weeks postop, full weight bearing (100%) without CAM boot will begin. Patients will continue to follow-up at 3 months and 6 months.
The research coordinator will ensure proper follow-up and will be responsible for data collection and input. After achieving the planned number of participants, the results of the two study sites will be gathered. Appropriate statistical analysis will be performed, and the results will be presented in a full manuscript format.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) Early Full Weight Bearing | Experimental | Other: Early Weight BearingFull weight bearing (100%) initiated at 4 weeks postoperatively |
| 2) Normal Full Weight Bearing | Active comparator | Other: Normal Weight BearingFull weight bearing (100%) initiated at 6 weeks postoperatively |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ankle fracture with syndesmotic disruption as assessed with intra-operative cotton test.
- Syndesmotic sprain (without fractures)
- Bimalleolar equivalent ankle fractures
- Bimalleolar ankle fractures
- Maisonneuve fractures
Key exclusion criteria (1 listed)
- 1) previous ankle surgery, 2) active local infection about the ankle, 3) chronic ankle deformity secondary to trauma or congenital, 4) ligamentous laxity, 5) pathologic fractures, 6) peripheral vascular disease, 7) peripheral neuropathy, 8) diabetes neuropathy and charcot, 9) open fractures, 10) poly trauma, 11) inability to provide informed consent, 12) symptomatic ankle osteoarthritis, 12) retained hardware, 13) pregnant, 14) metabolic bone disease, 15) history of chronic steroid use, 16) mal-reduced ankle fractures
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 |
|---|---|---|
| Early Weight BearingFull weight bearing (100%) initiated at 4 weeks postoperatively | Other | 1) Early Full Weight Bearing |
| Normal Weight BearingFull weight bearing (100%) initiated at 6 weeks postoperatively | Other | 2) Normal Full Weight Bearing |
Primary outcome
6 Month Reduction Quality
Time frame: 6 Months
The primary objective is to evaluate the reduction and maintenance of the reduction of ankle syndesmosis in 6 months after initiating full weight bearing (100%) at 4 weeks or 6 weeks postoperatively. This will be determined based on comparing the tibiofibular overlap, tibiofibular clear space and medial clear space preoperative values.
10 secondary outcomes
2 Week Reduction Quality
Time frame: 2 Weeks
4-6 Week Reduction Quality
Time frame: 4-6 Weeks
8-10 Week Reduction Quality
Time frame: 8-10 Weeks
3 Month Reduction Quality
Time frame: 3 Months
Reoperation or Revision
Time frame: 6 Months
OR Time
Time frame: 1 Day
Surgical Approach/Procedure Type
Time frame: 1 Day
Type of Additional Fixation
Time frame: 1 Day
Intraoperative Complications
Time frame: 1 Day
Postoperative Complications
Time frame: 30 Days
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 20 Mar 2026.
- Background: PubMed 15685077Thornes B, Shannon F, Guiney AM, Hession P, Masterson E. Suture-button syndesmosis fixation: accelerated rehabilitation and improved outcomes. Clin Orthop Relat Res. 2005 Feb;(431):207-12.
- Background: PubMed 21477543Degroot H, Al-Omari AA, El Ghazaly SA. Outcomes of suture button repair of the distal tibiofibular syndesmosis. Foot Ankle Int. 2011 Mar;32(3):250-6. doi: 10.3113/FAI.2011.0250.
- Background: PubMed 28129269Morellato J, Louati H, Bodrogi A, Stewart A, Papp S, Liew A, Gofton W. The Effect of Varying Tension of a Suture Button Construct in Fixation of the Tibiofibular Syndesmosis-Evaluation Using Stress Computed Tomography. J Orthop Trauma. 2017 Feb;31(2):103-110. doi: 10.1097/BOT.0000000000000737.
- BackgroundDynamic and Load-to-Failure Testing of the DePuy Synthes FIBULINK TM Syndesmosis Repair System and Arthrex Syndesmosis TightRope ® XP Implant System Materials and Methods. 2020.
- BackgroundDesai S. Syndesmosis Repair: 14 Patient Case Series.
- Background: PubMed 1262367Ramsey PL, Hamilton W. Changes in tibiotalar area of contact caused by lateral talar shift. J Bone Joint Surg Am. 1976 Apr;58(3):356-7.
- Background: PubMed 25948693Hunt KJ, Goeb Y, Behn AW, Criswell B, Chou L. Ankle Joint Contact Loads and Displacement With Progressive Syndesmotic Injury. Foot Ankle Int. 2015 Sep;36(9):1095-103. doi: 10.1177/1071100715583456. Epub 2015 May 6.
- Background: PubMed 25177153Porter DA, Jaggers RR, Barnes AF, Rund AM. Optimal management of ankle syndesmosis injuries. Open Access J Sports Med. 2014 Aug 5;5:173-82. doi: 10.2147/OAJSM.S41564. eCollection 2014.
- Background: PubMed 23949902Hunt KJ. Syndesmosis injuries. Curr Rev Musculoskelet Med. 2013 Dec;6(4):304-12. doi: 10.1007/s12178-013-9184-9.
- Background: PubMed 19857816Cottom JM, Hyer CF, Philbin TM, Berlet GC. Transosseous fixation of the distal tibiofibular syndesmosis: comparison of an interosseous suture and endobutton to traditional screw fixation in 50 cases. J Foot Ankle Surg. 2009 Nov-Dec;48(6):620-30. doi: 10.1053/j.jfas.2009.07.013. Epub 2009 Sep 15.
- BackgroundThornes, Brian FRCSI; McCartan, Damien MB. Ankle Syndesmosis Injuries Treated with the TightRopeTM Suture-Button Kit. Techniques in Foot & Ankle Surgery 5(1):p 45-53, March 2006.
- Background: PubMed 28761696Latham AJ, Goodwin PC, Stirling B, Budgen A. Ankle syndesmosis repair and rehabilitation in professional rugby league players: a case series report. BMJ Open Sport Exerc Med. 2017 Apr 1;3(1):e000175. doi: 10.1136/bmjsem-2016-000175. eCollection 2017.
- 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.
Amr A Abdelgawad, MD PhD MBA principal investigator
Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Weight Bearing and Normal Weight Bearing in people with Ankle Fractures and Bimalleolar Fractures, run by Maimonides Medical Center at 1 site in United States.
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 8 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. 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 United States. 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 Amr A Abdelgawad, MD PhD MBA (7182837400, aabdelgawad@maimonidesmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Month Reduction Quality (time frame: 6 Months). 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 NCT06085586, which also lists 18 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 20 Mar 2026.