Distal Tibia Fractures
Conditions
Keywords
Distal Tibia Fracture Screw
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.
Interventions
DEVICEZimmer MotionLoc Screw
Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
Sponsors
Zimmer Biomet
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up | 3 months | 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. |
| Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up | 3 months | Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up | 6 months | 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. |
| Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up | 12 months | 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. |
| Complications | 12 months | 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. |
| Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up | 6 months | Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT). |
| Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up | 12 months | Radiographic fracture healing is defined as bridging of three of the four cortices without fracture line (as seen on x-ray/CT). |
| Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up | 6 weeks | Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT). |
| Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up | 6 weeks | 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. |
Countries
Australia, Italy, South Korea, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 12 |
Baseline characteristics
| Characteristic | Group One | — |
|---|---|---|
| Age, Continuous | 53.5 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 4 participants | — |
| Region of Enrollment Italy | 13 participants | — |
| Region of Enrollment South Korea | 3 participants | — |
| Region of Enrollment United States | 12 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 6 / 32 |
| serious Total, serious adverse events | 1 / 32 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group One | 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 |
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group One | Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up | 3 participants |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group One | 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 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group One | 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 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group One | 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 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group One | Complications | Adverse Events | 8 adverse events |
| Group One | Complications | Device Related Adverse Events | 3 adverse events |
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).
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group One | Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up | 19 Participants |
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group One | Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up | 14 participants |
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group One | Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up | 2 participants |