Zimmer® MotionLoc® in Distal Tibia Fractures
- Conditions
- Distal Tibia Fractures
- Interventions
- Device: Zimmer MotionLoc Screw
- Registration Number
- NCT02717546
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
The objective of this observational prospective study is to systematically document the clinical outcomes of Zimmer MotionLoc Screws for Periarticular Locking Plate System applied to distal tibia fracture treatment and confirm safety and performance of the screws.
- Detailed Description
Primary Endpoint:
* Radiographic \& clinical fracture healing at 3 months post-surgery.
Secondary Endpoints:
* Complications
* Radiologic \& clinical fracture healing at 6 weeks, 3, 6, and 12 months post-surgery.
* Callus size \& distribution at 6 weeks, 3, 6, and 12 months post-surgery.
Radiologic fracture healing is defined as bridging of three of the four cortices as seen on x-ray/CT. Clinical healing will be assessed using the Function Index for Trauma (FIX-IT). The FIX-IT instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. It has been initially validated in patients with tibia and femur fractures.
Callus size of the anterior, posterior, and medial aspect will be assessed for each time point using a validated and published computational method.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- With or without fibula fracture involvement (treated or not treated by osteosynthesis)
- Close or open fractures Gustilo type I
- Unilateral or bilateral fractures
- Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program.
- Patients who give written consent to take part in the study by signing the "Patient Consent Form".
- Delay of surgery for more than two weeks.
- Open fractures Gustilo type II & III
- History of infection of the affected extremity
- Non-ambulatory patients
- Planned fixation strategy includes interfragmentary lag screw fixation of non-articular fractures.
- Addition of bone graft, bone graft substitute or bone morphogenetic protein (BMP).
- Immobilization with plaster.
- Likely problems with maintaining follow-up program (e.g. patients with no fixed address, plans to move during course of study)
- Not expected to survive the duration of follow-up program.
- Patients known to be pregnant or breastfeeding.
- Patients who are unwilling or unable to give consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group One Zimmer MotionLoc Screw Distal Tibia Fracture repaired with Zimmer MotionLoc Screw
- Primary Outcome Measures
Name Time Method Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up 3 months This measure will be assessed using the Function Index for Trauma (FIX-IT). The instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. Minimum (worst) score possible is 0 and Maximum (best) score possible is 12.
Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up 3 months Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).
- Secondary Outcome Measures
Name Time Method Complications 12 months Adverse Events were summed for all time points for the totality of the study. I.E. - complications reported for all sites at 6 weeks, 3 months, 6 months, and 12 months were summed and reported as a single secondary outcome measure for the study.
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up 6 weeks This measure will be assessed using the Function Index for Trauma (FIX-IT) The instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. Minimum (worst) score possible is 0 and Maximum (best) score possible is 12.
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up 6 months This measure will be assessed using the Function Index for Trauma (FIX-IT) The instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. Minimum (worst) score possible is 0 and Maximum (best) score possible is 12.
Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up 6 months Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up 12 months This measure will be assessed using the Function Index for Trauma (FIX-IT) The instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. Minimum (worst) score possible is 0 and Maximum (best) score possible is 12.
Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up 6 weeks Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).
Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up 12 months Radiographic fracture healing is defined as bridging of three of the four cortices without fracture line (as seen on x-ray/CT).
Trial Locations
- Locations (7)
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Donald B. Slocum Research and Education Foundation
🇺🇸Eugene, Oregon, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Mackay Specialist Day Hospital
🇦🇺Mount Pleasant, Australia
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
The Dudley Group NHS Foundation Trust
🇬🇧Dudley, West Midlands, United Kingdom