Zimmer® MotionLoc® in Distal Tibia Fractures

Distal Tibia Fractures Clinical Trial

Official title:

Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717546
• Other study ID #: CSE2014-08T
• Status: Completed
• Start date: February 2016
• Est. completion date: January 15, 2020

Study information

• Verified date: July 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 15, 2020
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Tibia Fractures
• Fractures, Bone
• Tibial Fractures

Intervention

Device:
• Zimmer MotionLoc Screw
Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.

Locations

Country	Name	City	State
Australia	Mackay Specialist Day Hospital	Mount Pleasant
Italy	Azienda Ospedaliera Universitaria Senese	Siena
Korea, Republic of	Korea University Anam Hospital	Seoul
United Kingdom	The Dudley Group NHS Foundation Trust	Dudley	West Midlands
United States	Donald B. Slocum Research and Education Foundation	Eugene	Oregon
United States	Indiana University	Indianapolis	Indiana
United States	Springfield Clinic	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Australia,  Italy,  Korea, Republic of,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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