DePuy Synthes Variable Angle LCP Patella Plating System Study

Trauma Clinical Trial

Official title:

Utility of the Variable Angle LCP Patella Plating System for Traumatic Patellar Fractures: A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05824676
• Other study ID #: HHC-2022-0283
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: December 2027

Study information

• Verified date: February 2023
• Source: Hartford Hospital
• Contact: Jake R Corsa, Bsc
• Phone: 860-972-6685
• Email: Jake.Corsa[@]hhchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Depuy Synthes Locking Compression Plate (LCP) Variable Angle Patella Plating System is an FDA approved device. The purpose of this study is to see how well the Depuy Synthes LCP Variable Plating System work in fixing a broken kneecap (patella). Depuy says that the device will improve healing when compared to traditional ways of repairing a broken patella.

The goal of this randomized control trial is to learn how well the LCP Variable Plating System works to fix a broken patella (kneecap) compared to traditional fixation methods, in male and females, age 18 to 74, with a patellar fracture, and being treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital. The main question it aims to answer are:

• To understand if the Depuy Synthes LCP Variable Angle Plating System will provide a better way to help patients recover from a broken patella.

Participants will evaluated at specific time points: post-op day 1, 6 weeks, 3 months, 6 months, and 12 month post-surgery. Participants will be asked to:

• Complete surveys at all evaluation timepoints.

• Have x-rays(radiographs) taken at the 6 week, 3 month, 6 month, 9 month, and 1 year timepoints.

• Participants will have a passive range of motion tests done at 6 week, 3 month, 6 month, 9 month, and 1 year timepoints.

• Participants would have strength and balance tests done at the 3 month, 6 month, 9 month, and 1 year timepoints.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Males and females

• Age between 18 and 74 years old (inclusive)

• Patellar fracture

• Treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital

Exclusion Criteria:

• Age greater than or equal to 75 or less than 18

• Patients that are non-ambulatory/limited ambulation prior to their injury

• Previous patellar fracture

• Pre-existing osteoarthritis of the knee

• Ipsilateral femoral or tibia fractures

Related Conditions & MeSH terms

• Fractures, Bone
• Knee Cap
• Knee Deformity
• Knee Discomfort
• Patella Fracture
• Trauma

Intervention

Device:
• Variable Angle LCP Patella Plating System
FDA approved device, 510K number of, K210408. The Variable Angle LCP Patella Plating System is a device that can be formed to a patients specific need with various anchoring points to best fix what is needed for fixation.
• Traditional Fixation
Traditional fixation methods for patellar fracture (screws, suture fixation, wire fixation, other plates).

Locations

Country	Name	City	State
United States	Hartford HealthCare The Bone and Joint Institute	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison	Comparing the DePuy Synthes LCP Variable Patella Plating System to tradition fixation methods using clinical outcomes measures.	1 year
Primary	DePuy Synthes LCP Variable Angle Patella Plating System functional outcomes comparison	Comparing the DePuy Synthes LCP Variable Patella Plating System to traditional fixation methods using functional outcomes measures.	1 year
Primary	DePuy Synthes LCP Variable Angle Patella Plating System patient reported outcomes comparison	Comparing the DePuy Synthes LCP Variable Angle Patella Plating System to traditional fixation methods using patient/participant reported outcomes measures.	1 year
Secondary	Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)	PROMIS Global-10 is a validated 10-question survey used to assess health care-related quality of life measures such as a participant's function, mental health, numeric pain scale for the general population. The scale runs from 0 to 20. 0 represents severe impairment and low quality of life. A score of 20 represents the best possible quality of life.	Post-op day 1
Secondary	Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)	PROMIS Global-10 is a validated 10-question survey used to assess health care-related quality of life measures such as a participant's function, mental health, numeric pain scale for the general population. The scale runs from 0 to 20. 0 represents severe impairment and low quality of life. A score of 20 represents the best possible quality of life.	6 weeks
Secondary	Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)	PROMIS Global-10 is a validated 10-question survey used to assess health care-related quality of life measures such as a participant's function, mental health, numeric pain scale for the general population. The scale runs from 0 to 20. 0 represents severe impairment and low quality of life. A score of 20 represents the best possible quality of life.	3 months
Secondary	Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)	PROMIS Global-10 is a validated 10-question survey used to assess health care-related quality of life measures such as a participant's function, mental health, numeric pain scale for the general population. The scale runs from 0 to 20. 0 represents severe impairment and low quality of life. A score of 20 represents the best possible quality of life.	6 months
Secondary	Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)	PROMIS Global-10 is a validated 10-question survey used to assess health care-related quality of life measures such as a participant's function, mental health, numeric pain scale for the general population. The scale runs from 0 to 20. 0 represents severe impairment and low quality of life. A score of 20 represents the best possible quality of life.	9 months
Secondary	Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)	PROMIS Global-10 is a validated 10-question survey used to assess health care-related quality of life measures such as a participant's function, mental health, numeric pain scale for the general population. The scale runs from 0 to 20. 0 represents severe impairment and low quality of life. A score of 20 represents the best possible quality of life.	1 year
Secondary	Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)	ADL-KOS is a 14 question survey that assesses a participant's functional ability related to their knee and how knee symptoms may affect their activities of daily living. The scoring for the ADL-KOS runs from 0 to 100. 0 representing the lowest possible functional ability, and 100 representing the maximum functional ability possible.	Post-op day 1
Secondary	Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)	ADL-KOS is a 14 question survey that assesses a participant's functional ability related to their knee and how knee symptoms may affect their activities of daily living. The scoring for the ADL-KOS runs from 0 to 100. 0 representing the lowest possible functional ability, and 100 representing the maximum functional ability possible.	6 weeks
Secondary	Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)	ADL-KOS is a 14 question survey that assesses a participant's functional ability related to their knee and how knee symptoms may affect their activities of daily living. The scoring for the ADL-KOS runs from 0 to 100. 0 representing the lowest possible functional ability, and 100 representing the maximum functional ability possible.	3 months
Secondary	Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)	ADL-KOS is a 14 question survey that assesses a participant's functional ability related to their knee and how knee symptoms may affect their activities of daily living. The scoring for the ADL-KOS runs from 0 to 100. 0 representing the lowest possible functional ability, and 100 representing the maximum functional ability possible.	6 months
Secondary	Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)	ADL-KOS is a 14 question survey that assesses a participant's functional ability related to their knee and how knee symptoms may affect their activities of daily living. The scoring for the ADL-KOS runs from 0 to 100. 0 representing the lowest possible functional ability, and 100 representing the maximum functional ability possible.	9 months
Secondary	Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)	ADL-KOS is a 14 question survey that assesses a participant's functional ability related to their knee and how knee symptoms may affect their activities of daily living. The scoring for the ADL-KOS runs from 0 to 100. 0 representing the lowest possible functional ability, and 100 representing the maximum functional ability possible.	1 year
Secondary	Radiographs	Radiographic imaging will be taken at each of the study visits starting at week 6 to assess healing and ensure that there are no issues with the hardware. Radiographic healing will be assessed by the congruity of the cortical bone and reduction of fracture lines. Radiographs will also be used to determine if there is any failure of the hardware. (i.e. loosening of the screws or wires or instrument breakage).	6 weeks
Secondary	Radiographs	Radiographic imaging will be taken at each of the study visits starting at week 6 to assess healing and ensure that there are no issues with the hardware. Radiographic healing will be assessed by the congruity of the cortical bone and reduction of fracture lines. Radiographs will also be used to determine if there is any failure of the hardware. (i.e. loosening of the screws or wires or instrument breakage).	3 months
Secondary	Radiographs	Radiographic imaging will be taken at each of the study visits starting at week 6 to assess healing and ensure that there are no issues with the hardware. Radiographic healing will be assessed by the congruity of the cortical bone and reduction of fracture lines. Radiographs will also be used to determine if there is any failure of the hardware. (i.e. loosening of the screws or wires or instrument breakage).	6 months
Secondary	Radiographs	Radiographic imaging will be taken at each of the study visits starting at week 6 to assess healing and ensure that there are no issues with the hardware. Radiographic healing will be assessed by the congruity of the cortical bone and reduction of fracture lines. Radiographs will also be used to determine if there is any failure of the hardware. (i.e. loosening of the screws or wires or instrument breakage).	9 months
Secondary	Radiographs	Radiographic imaging will be taken at each of the study visits starting at week 6 to assess healing and ensure that there are no issues with the hardware. Radiographic healing will be assessed by the congruity of the cortical bone and reduction of fracture lines. Radiographs will also be used to determine if there is any failure of the hardware. (i.e. loosening of the screws or wires or instrument breakage).	1 year
Secondary	Passive Range of Motion (ROM)	Passive ROM will be assessed at each study visit starting at 6 weeks. Knee flexion and extension will be measured using a goniometer (an instrument that measures angles of joints). Participants will be asked to sit with their hips at 90° and lower leg hanging off the exam table or chair. The center of the goniometer will be placed at the rotational axis of the knee joint and the two arms of the goniometer will be aligned with the femoral shaft and tibial shaft. The participant's leg will then be maximally flexed and the goniometer read to determine the total flexion range, and then the participant's leg will be straightened to determine the maximum extension angle. The total knee arc of motion will be recorded as the addition of these two angles.	6 weeks
Secondary	Passive Range of Motion (ROM)	Passive ROM will be assessed at each study visit starting at 6 weeks. Knee flexion and extension will be measured using a goniometer (an instrument that measures angles of joints). Participants will be asked to sit with their hips at 90° and lower leg hanging off the exam table or chair. The center of the goniometer will be placed at the rotational axis of the knee joint and the two arms of the goniometer will be aligned with the femoral shaft and tibial shaft. The participant's leg will then be maximally flexed and the goniometer read to determine the total flexion range, and then the participant's leg will be straightened to determine the maximum extension angle. The total knee arc of motion will be recorded as the addition of these two angles.	3 months
Secondary	Passive Range of Motion (ROM)	Passive ROM will be assessed at each study visit starting at 6 weeks. Knee flexion and extension will be measured using a goniometer (an instrument that measures angles of joints). Participants will be asked to sit with their hips at 90° and lower leg hanging off the exam table or chair. The center of the goniometer will be placed at the rotational axis of the knee joint and the two arms of the goniometer will be aligned with the femoral shaft and tibial shaft. The participant's leg will then be maximally flexed and the goniometer read to determine the total flexion range, and then the participant's leg will be straightened to determine the maximum extension angle. The total knee arc of motion will be recorded as the addition of these two angles.	6 months
Secondary	Passive Range of Motion (ROM)	Passive ROM will be assessed at each study visit starting at 6 weeks. Knee flexion and extension will be measured using a goniometer (an instrument that measures angles of joints). Participants will be asked to sit with their hips at 90° and lower leg hanging off the exam table or chair. The center of the goniometer will be placed at the rotational axis of the knee joint and the two arms of the goniometer will be aligned with the femoral shaft and tibial shaft. The participant's leg will then be maximally flexed and the goniometer read to determine the total flexion range, and then the participant's leg will be straightened to determine the maximum extension angle. The total knee arc of motion will be recorded as the addition of these two angles.	9 months
Secondary	Passive Range of Motion (ROM)	Passive ROM will be assessed at each study visit starting at 6 weeks. Knee flexion and extension will be measured using a goniometer (an instrument that measures angles of joints). Participants will be asked to sit with their hips at 90° and lower leg hanging off the exam table or chair. The center of the goniometer will be placed at the rotational axis of the knee joint and the two arms of the goniometer will be aligned with the femoral shaft and tibial shaft. The participant's leg will then be maximally flexed and the goniometer read to determine the total flexion range, and then the participant's leg will be straightened to determine the maximum extension angle. The total knee arc of motion will be recorded as the addition of these two angles.	1 year
Secondary	Strength	Quadriceps muscle strength will be assessed starting at each visit starting at the 3 month post-operative visit. Strength measures will be assessed using a hand held dynamometer (a device that measures force). The strength assessment will be performed with the participant in a seated position with hips at 90°. The dynamometer will be placed mid tibial shaft and the testers other hand will be placed just above the knee to provide stability. The participant will be instructed to try to straighten their leg against the resistance of the examiner. The strength measures will be repeated 3 times for consistency. Additionally, the strength of the non-injured quadriceps will also be assessed to determine if there is a side to side strength deficit.	3 months
Secondary	Strength	Quadriceps muscle strength will be assessed starting at each visit starting at the 3 month post-operative visit. Strength measures will be assessed using a hand held dynamometer (a device that measures force). The strength assessment will be performed with the participant in a seated position with hips at 90°. The dynamometer will be placed mid tibial shaft and the testers other hand will be placed just above the knee to provide stability. The participant will be instructed to try to straighten their leg against the resistance of the examiner. The strength measures will be repeated 3 times for consistency. Additionally, the strength of the non-injured quadriceps will also be assessed to determine if there is a side to side strength deficit.	6 months
Secondary	Strength	Quadriceps muscle strength will be assessed starting at each visit starting at the 3 month post-operative visit. Strength measures will be assessed using a hand held dynamometer (a device that measures force). The strength assessment will be performed with the participant in a seated position with hips at 90°. The dynamometer will be placed mid tibial shaft and the testers other hand will be placed just above the knee to provide stability. The participant will be instructed to try to straighten their leg against the resistance of the examiner. The strength measures will be repeated 3 times for consistency. Additionally, the strength of the non-injured quadriceps will also be assessed to determine if there is a side to side strength deficit.	9 months
Secondary	Strength	Quadriceps muscle strength will be assessed starting at each visit starting at the 3 month post-operative visit. Strength measures will be assessed using a hand held dynamometer (a device that measures force). The strength assessment will be performed with the participant in a seated position with hips at 90°. The dynamometer will be placed mid tibial shaft and the testers other hand will be placed just above the knee to provide stability. The participant will be instructed to try to straighten their leg against the resistance of the examiner. The strength measures will be repeated 3 times for consistency. Additionally, the strength of the non-injured quadriceps will also be assessed to determine if there is a side to side strength deficit.	1 year
Secondary	Balance	Balance assessments will also take place at each visit starting at the 3 month post-operative visit. Static balance will be assessed using a portable force plate. Participants will be asked to perform four balance tasks. The first will be with both feet together hands on their hips staring straight ahead. The second assessment will be both feet together, hands on their hips with their eyes closed. The final two assessments will be single limb stances with eyes open. One single limb stance will be used to assess the operative limb the other the non-operative limb. Each balance task will be measured for 20 seconds. During this time investigator will record the medial lateral weight shift, anterior posterior weight shift, and sway area, a 90% elliptical fit of the weight shift with the minor and major axes defined as the maximum and minimum sway values in anterior/posterior and medial/lateral directions.	3 months
Secondary	Balance	Balance assessments will also take place at each visit starting at the 3 month post-operative visit. Static balance will be assessed using a portable force plate. Participants will be asked to perform four balance tasks. The first will be with both feet together hands on their hips staring straight ahead. The second assessment will be both feet together, hands on their hips with their eyes closed. The final two assessments will be single limb stances with eyes open. One single limb stance will be used to assess the operative limb the other the non-operative limb. Each balance task will be measured for 20 seconds. During this time investigator will record the medial lateral weight shift, anterior posterior weight shift, and sway area, a 90% elliptical fit of the weight shift with the minor and major axes defined as the maximum and minimum sway values in anterior/posterior and medial/lateral directions.	6 months
Secondary	Balance	Balance assessments will also take place at each visit starting at the 3 month post-operative visit. Static balance will be assessed using a portable force plate. Participants will be asked to perform four balance tasks. The first will be with both feet together hands on their hips staring straight ahead. The second assessment will be both feet together, hands on their hips with their eyes closed. The final two assessments will be single limb stances with eyes open. One single limb stance will be used to assess the operative limb the other the non-operative limb. Each balance task will be measured for 20 seconds. During this time investigator will record the medial lateral weight shift, anterior posterior weight shift, and sway area, a 90% elliptical fit of the weight shift with the minor and major axes defined as the maximum and minimum sway values in anterior/posterior and medial/lateral directions.	9 months
Secondary	Balance	Balance assessments will also take place at each visit starting at the 3 month post-operative visit. Static balance will be assessed using a portable force plate. Participants will be asked to perform four balance tasks. The first will be with both feet together hands on their hips staring straight ahead. The second assessment will be both feet together, hands on their hips with their eyes closed. The final two assessments will be single limb stances with eyes open. One single limb stance will be used to assess the operative limb the other the non-operative limb. Each balance task will be measured for 20 seconds. During this time investigator will record the medial lateral weight shift, anterior posterior weight shift, and sway area, a 90% elliptical fit of the weight shift with the minor and major axes defined as the maximum and minimum sway values in anterior/posterior and medial/lateral directions.	1 year