Zimmer® MotionLoc® in Distal Tibia Fractures

Study 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.

Official Title
-----------------
Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study

Conditions
-----------------
Distal Tibia Fractures

Intervention / Treatment
-----------------
* Device: Zimmer MotionLoc Screw


Participation Criteria
=================
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. Patients who are unwilling or unable to give consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group One<br>Distal Tibia Fracture repaired with Zimmer MotionLoc Screw | Device: Zimmer MotionLoc Screw<br>* Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up | 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. | 3 months | 
| Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up | Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | 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. | 12 months | 
| Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up | 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. | 6 weeks | 
| Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up | 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. | 6 months | 
| Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up | 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. | 12 months | 
| Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up | Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT). | 6 weeks | 
| Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up | Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT). | 6 months | 
| Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up | Radiographic fracture healing is defined as bridging of three of the four cortices without fracture line (as seen on x-ray/CT). | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Distal Tibia Fracture Screw