N/A
N=32
Zimmer® MotionLoc® in Distal Tibia Fractures
Distal Tibia Fractures
Bottom Line
View on ClinicalTrials.gov: NCT02717546 ↗Enrolled (actual)
32
Serious AEs
3.1%
Results posted
Aug 2021
Primary outcome: Primary: Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up — 7.5 score on scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Zimmer MotionLoc Screw (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up |
7.5 | — |
| PRIMARY Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up |
3 | — |
| SECONDARY Complications |
8; 3 | — |
| SECONDARY Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up |
4.4 | — |
| SECONDARY Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up |
10.9 | — |
| SECONDARY Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up |
11.5 | — |
| SECONDARY Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up |
2 | — |
| SECONDARY Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up |
14 | — |
| SECONDARY Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up |
19 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02717546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.