Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

NCT ID: NCT06085586

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-13
• Study Completion Date: 2026-06-30

Brief 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 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.

Conditions

Ankle Fractures; Bimalleolar Fractures; Syndesmotic Injuries; Bimalleolar Equivalent Fracture; Maisonneuve Fracture; Trimalleolar Fractures; Ankle Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1) Early Full Weight Bearing

Full weight bearing (100%) initiated at 4 weeks postoperatively

Group Type: EXPERIMENTAL

Early Weight Bearing

Intervention Type: OTHER

Full weight bearing (100%) initiated at 4 weeks postoperatively

2) Normal Full Weight Bearing

Full weight bearing (100%) initiated at 6 weeks postoperatively

Group Type: ACTIVE_COMPARATOR

Normal Weight Bearing

Intervention Type: OTHER

Full weight bearing (100%) initiated at 6 weeks postoperatively

Interventions

Early Weight Bearing

Full weight bearing (100%) initiated at 4 weeks postoperatively

Intervention Type: OTHER

Normal Weight Bearing

Full weight bearing (100%) initiated at 6 weeks postoperatively

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: collaborator

Maimonides Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amr A Abdelgawad, MD PhD MBA

Role: PRINCIPAL_INVESTIGATOR

Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amr A Abdelgawad, MD PhD MBA

Role: CONTACT

aabdelgawad@maimonidesmed.org

7182837400

Ariel N Rodriguez, MD

Role: CONTACT

arrodriguez@maimonidesmed.org

7182837400

Facility Contacts

Antonios Likourezos

Role: primary

alikourezos@maimonidesmed.org

718-283-6896

References

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Reference Type: BACKGROUND

PMID: 28129269 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15685077 (View on PubMed)

Degroot 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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Desai S. Syndesmosis Repair: 14 Patient Case Series.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 1262367 (View on PubMed)

Hunt 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.

Reference Type: BACKGROUND

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Porter 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.

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Cottom 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.

Reference Type: BACKGROUND

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Thornes, 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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 28761696 (View on PubMed)

Cotton FJ. Dislocations and Joint-Fractures. Philadelphia: W. B. Saunders Company, 1910.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 9391813 (View on PubMed)

Harper MC, Keller TS. A radiographic evaluation of the tibiofibular syndesmosis. Foot Ankle. 1989 Dec;10(3):156-60. doi: 10.1177/107110078901000308.

Reference Type: BACKGROUND

PMID: 2613128 (View on PubMed)

Leeds HC, Ehrlich MG. Instability of the distal tibiofibular syndesmosis after bimalleolar and trimalleolar ankle fractures. J Bone Joint Surg Am. 1984 Apr;66(4):490-503.

Reference Type: BACKGROUND

PMID: 6423645 (View on PubMed)

Rigby RB, Cottom JM. Does the Arthrex TightRope(R) provide maintenance of the distal tibiofibular syndesmosis? A 2-year follow-up of 64 TightRopes(R) in 37 patients. J Foot Ankle Surg. 2013 Sep-Oct;52(5):563-7. doi: 10.1053/j.jfas.2013.04.013. Epub 2013 Jun 14.

Reference Type: BACKGROUND

PMID: 23770192 (View on PubMed)

Mukhopadhyay S, Metcalfe A, Guha AR, Mohanty K, Hemmadi S, Lyons K, O'Doherty D. Malreduction of syndesmosis--are we considering the anatomical variation? Injury. 2011 Oct;42(10):1073-6. doi: 10.1016/j.injury.2011.03.019. Epub 2011 May 6.

Reference Type: BACKGROUND

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2022-08-15-MMC

Identifier Type: -

Identifier Source: org_study_id