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Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Primary Purpose

Ankle Fractures, Bimalleolar Fractures, Syndesmotic Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Weight Bearing
Normal Weight Bearing
Sponsored by
Maimonides Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures focused on measuring Ankle Fractures, Bimalleolar Fractures, Bimalleolar Equivalent Fracture, Trimalleolar Fractures, Maisonneuve Fractures, Syndesmotic Injuries, Ankle Dislocations

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maimonides Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1) Early Full Weight Bearing

2) Normal Full Weight Bearing

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Reoperation or Revision
Unplanned Reoperation or late-stage revision
OR Time
Operating Room Time in Minutes
Surgical Approach/Procedure Type
Surgical Approach/Procedure Type
Type of Additional Fixation
Type of Additional Fixation
Intraoperative Complications
Any complications that occurred intraoperatively
Postoperative Complications
Any complications that occurred postoperatively within 30 Days

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Maimonides Medical Center
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT06085586
Brief Title
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Official Title
Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimonides Medical Center
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures, Bimalleolar Fractures, Syndesmotic Injuries, Bimalleolar Equivalent Fracture, Maisonneuve Fracture, Trimalleolar Fractures, Ankle Dislocation
Keywords
Ankle Fractures, Bimalleolar Fractures, Bimalleolar Equivalent Fracture, Trimalleolar Fractures, Maisonneuve Fractures, Syndesmotic Injuries, Ankle Dislocations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1) Early Full Weight Bearing
Arm Type
Experimental
Arm Description
Full weight bearing (100%) initiated at 4 weeks postoperatively
Arm Title
2) Normal Full Weight Bearing
Arm Type
Active Comparator
Arm Description
Full weight bearing (100%) initiated at 6 weeks postoperatively
Intervention Type
Other
Intervention Name(s)
Early Weight Bearing
Intervention Description
Full weight bearing (100%) initiated at 4 weeks postoperatively
Intervention Type
Other
Intervention Name(s)
Normal Weight Bearing
Intervention Description
Full weight bearing (100%) initiated at 6 weeks postoperatively
Primary Outcome Measure Information:
Title
6 Month Reduction Quality
Description
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.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
2 Week Reduction Quality
Description
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.
Time Frame
2 Weeks
Title
4-6 Week Reduction Quality
Description
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.
Time Frame
4-6 Weeks
Title
8-10 Week Reduction Quality
Description
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.
Time Frame
8-10 Weeks
Title
3 Month Reduction Quality
Description
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.
Time Frame
3 Months
Title
Reoperation or Revision
Description
Unplanned Reoperation or late-stage revision
Time Frame
6 Months
Title
OR Time
Description
Operating Room Time in Minutes
Time Frame
1 Day
Title
Surgical Approach/Procedure Type
Description
Surgical Approach/Procedure Type
Time Frame
1 Day
Title
Type of Additional Fixation
Description
Type of Additional Fixation
Time Frame
1 Day
Title
Intraoperative Complications
Description
Any complications that occurred intraoperatively
Time Frame
1 Day
Title
Postoperative Complications
Description
Any complications that occurred postoperatively within 30 Days
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr A Abdelgawad, MD PhD MBA
Phone
7182837400
Email
aabdelgawad@maimonidesmed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel N Rodriguez, MD
Phone
7182837400
Email
arrodriguez@maimonidesmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr A Abdelgawad, MD PhD MBA
Organizational Affiliation
Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonios Likourezos
Phone
718-283-6896
Email
alikourezos@maimonidesmed.org
First Name & Middle Initial & Last Name & Degree
Amr A Abdelgawad, MD PhD MBA
First Name & Middle Initial & Last Name & Degree
Aaron W Lam, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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15685077
Citation
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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.
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Morellato 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.
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Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

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