Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Distal Tibia Fractures
- Sponsor
- Zimmer Biomet
- Enrollment
- 32
- Locations
- 7
- Primary Endpoint
- Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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".
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up
Time Frame: 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
Time Frame: 3 months
Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).
Secondary Outcomes
- Complications(12 months)
- Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up(6 weeks)
- Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up(6 months)
- Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up(6 months)
- Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up(12 months)
- Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up(6 weeks)
- Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up(12 months)