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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.
Primary Endpoint:
Secondary Endpoints:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group One | Distal Tibia Fracture repaired with Zimmer MotionLoc Screw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer MotionLoc Screw | Device | Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Kacy Arnold, RN MBA | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Springfield Clinic | Springfield | Illinois | 62703 | United States | ||
| Indiana University |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on scale | 3 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Compartment Syndrome | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient diagnosed with diabetes. | Endocrine disorders | ISO 14155:2011 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Boylan, Clinical Affairs Manager | Zimmer Biomet | 574.527.7934 | ryan.boylan@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2016 | Apr 28, 2021 | Prot_SAP_000.pdf |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Indianapolis |
| Indiana |
| 46266 |
| United States |
| Donald B. Slocum Research and Education Foundation | Eugene | Oregon | 97408 | United States |
| Mackay Specialist Day Hospital | Mount Pleasant | QLD 4740 | Australia |
| Azienda Ospedaliera Universitaria Senese | Siena | Italy |
| Korea University Anam Hospital | Seoul | South Korea |
| The Dudley Group NHS Foundation Trust | Dudley | West Midlands | DY12HQ | United Kingdom |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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|
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| 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). | 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. | Posted | Number | participants | 3 months |
|
|
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| 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. | 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. | Posted | Number | adverse events | 12 months |
|
|
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on scale | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on scale | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
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| 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). | 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. | Posted | Number | participants | 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). | 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. | Posted | Number | participants | 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). | 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. | Posted | Count of Participants | Participants | 12 months |
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| 0 |
| 32 |
| 1 |
| 32 |
| 6 |
| 32 |
| Evaluated for DVT (Swelling and pain). | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
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| Ankle collapse -9 degrees varus. | Product Issues | ISO 14155:2011 | Systematic Assessment |
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| Evaluated for DVT. | Vascular disorders | ISO 14155:2011 | Systematic Assessment |
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| Pop in operative leg followed by pain. | Product Issues | ISO 14155:2011 | Systematic Assessment |
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| Painful hardware. | Product Issues | ISO 14155:2011 | Systematic Assessment |
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| Left hip pain. | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
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| Scant serious drainage. | Infections and infestations | ISO 14155:2011 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | ISO 14155:2011 | Systematic Assessment |
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| Numbness in knee | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
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