Clinical trial NCT02717546: Zimmer® MotionLoc® in Distal Tibia Fractures
Official title: Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Tibia Fractures
Keywords: Distal Tibia Fracture Screw
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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.

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.

Primary outcomes:
measure: Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up
timeFrame: 3 months
measure: Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Complications
timeFrame: 12 months
measure: Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up
timeFrame: 6 weeks
measure: Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up
timeFrame: 6 months
measure: Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up
timeFrame: 12 months
measure: Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up
timeFrame: 6 weeks
measure: Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up
timeFrame: 6 months
measure: Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up
timeFrame: 12 months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Eugene
country: United States
facility: Donald B. Slocum Research and Education Foundation
state: Oregon
city: Mount Pleasant
country: Australia
facility: Mackay Specialist Day Hospital
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: Zimmer Biomet
name: Kacy Arnold, RN MBA
role: STUDY_DIRECTOR
References: