Trial Outcomes & Findings for Zimmer® MotionLoc® in Distal Tibia Fractures (NCT NCT02717546)

NCT ID: NCT02717546

Last Updated: 2021-08-04

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 32 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-08-04

Participant Flow

Participant milestones

Measure	Group One Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Overall Study STARTED	32
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Group One Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Overall Study Lost to Follow-up	12

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group One n=32 Participants Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Age, Continuous	53.5 years n=32 Participants
Sex: Female, Male Female	16 Participants n=32 Participants
Sex: Female, Male Male	16 Participants n=32 Participants
Region of Enrollment South Korea	3 participants n=32 Participants
Region of Enrollment United States	12 participants n=32 Participants
Region of Enrollment Italy	13 participants n=32 Participants
Region of Enrollment Australia	4 participants n=32 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Thirty-two subjects were enrolled globally. At 3 months follow-up, 29 subjects completed their visit and contributed to study data collection, thus 29 subjects were analyzed for this 3 month primary endpoint. However, the participation flow reports 20 subjects completed, which is reporting the number of subjects that were available for data collection at the 12 month 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.

Outcome measures

Measure	Group One n=29 Participants Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
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 Interval 6.6 to 8.4

PRIMARY outcome

Timeframe: 3 months

Population: Thirty-two subjects were enrolled globally. After 3 months follow-up, 29 subjects remained in the study for data collection, thus 29 subjects were analyzed for the primary endpoint. However, the participation flow reports 20 subjects completed, which is reporting the number of subjects that were available for data collection at the 12 month follow-up.

Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).

Outcome measures

Measure	Group One n=29 Participants Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up	3 participants

SECONDARY outcome

Timeframe: 12 months

Population: Complications were reported for all 32 subjects. If a subject was lost to follow-up, all existing complications for that subject remained in the data for reporting.

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.

Outcome measures

Measure	Group One n=32 Participants Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Complications Adverse Events	8 adverse events
Complications Device Related Adverse Events	3 adverse events

SECONDARY outcome

Timeframe: 6 weeks

Population: Thirty-two subjects were enrolled globally. At 6 weeks follow-up, 28 subjects completed their visit and contributed to study data collection, thus 28 subjects were analyzed for this 6 week secondary endpoint. However, the participation flow reports 20 subjects completed, which is reporting the number of subjects that were available for data collection at the 12 month 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.

Outcome measures

Measure	Group One n=28 Participants Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up	4.4 score on scale Interval 3.6 to 5.1

SECONDARY outcome

Timeframe: 6 months

Population: Thirty-two subjects were enrolled globally. At 6 months follow-up, 27 subjects completed their visit and contributed to study data collection, thus 27 subjects were analyzed for this 6 month secondary endpoint. However, the participation flow reports 20 subjects completed, which is reporting the number of subjects that were available for data collection at the 12 month 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.

Outcome measures

Measure	Group One n=27 Participants Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up	10.9 score on scale Interval 10.1 to 11.6

SECONDARY outcome

Timeframe: 12 months

Population: Thirty-two subjects were enrolled globally. At 12 months follow-up, 20 subjects completed their visit and contributed to study data collection, thus 20 subjects were analyzed for this 12 month secondary endpoint.

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.

Outcome measures

Measure	Group One n=20 Participants Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up	11.5 score on a scale Interval 11.0 to 12.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Thirty-two subjects were enrolled globally. After 6 weeks follow-up, 28 subjects completed their visit and contributed to study data collection, thus 28 subjects were analyzed for this 6 week secondary endpoint. However, the participation flow reports 20 subjects completed, which is reporting the number of subjects that were available for data collection at the 12 month follow-up.

Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).

Outcome measures

Measure	Group One n=28 Participants Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up	2 participants

SECONDARY outcome

Timeframe: 6 months

Population: Thirty-two subjects were enrolled globally. After 6 months follow-up, 27 subjects completed their visit and contributed to study data collection, thus 27 subjects were analyzed for this 6 month secondary endpoint. However, the participation flow reports 20 subjects completed, which is reporting the number of subjects that were available for data collection at the 12 month follow-up.

Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).

Outcome measures

Measure	Group One n=27 Participants Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up	14 participants

SECONDARY outcome

Timeframe: 12 months

Population: Radiographic fracture healing at 12 months follow-up for subjects that completed their clinic visit, or showed radiographic union prior to lost to follow-up. Twenty subjects completed their 12 month follow-up visit, of these, 15 showed radiographic union. In addition to these 15 subjects, 4 subjects had previously shown radiographic healing; however, they did not complete their 12 month protocol visit but were included in this 12 month results for a total of 24 participants analyzed.

Radiographic fracture healing is defined as bridging of three of the four cortices without fracture line (as seen on x-ray/CT).

Outcome measures

Measure	Group One n=24 Participants Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up	19 Participants

Adverse Events

Group One

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group One n=32 participants at risk Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Vascular disorders Compartment Syndrome	3.1% 1/32 • Number of events 32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.

Other adverse events

Measure	Group One n=32 participants at risk Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Zimmer MotionLoc Screw: Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Endocrine disorders Patient diagnosed with diabetes.	3.1% 1/32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.
Vascular disorders Evaluated for DVT (Swelling and pain).	3.1% 1/32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.
Product Issues Ankle collapse -9 degrees varus.	3.1% 1/32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.
Vascular disorders Evaluated for DVT.	3.1% 1/32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.
Product Issues Pop in operative leg followed by pain.	3.1% 1/32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.
Product Issues Painful hardware.	3.1% 1/32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Left hip pain.	3.1% 1/32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.
Infections and infestations Scant serious drainage.	3.1% 1/32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.
Gastrointestinal disorders Diarrhea	3.1% 1/32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Numbness in knee	3.1% 1/32 • Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first. ISO definition is not materially different from clinicaltrials.gov definitions.

Additional Information

Ryan Boylan, Clinical Affairs Manager

Zimmer Biomet

Phone: 574.527.7934

Email: ryan.boylan@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place