An interventional study of Variable Angle LCP Patella Plating System and Traditional Fixation in Trauma, Patella Fracture and Knee Cap, sponsored by Hartford Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Hartford Hospital · Not applicable, Interventional, and Treatment
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:
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:
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 36 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will have 18 randomly selected participants, who will receive the Depuy Synthes LCP Patella Plating System for patella fracture.
Device: Variable Angle LCP Patella Plating System
This group will have 18 randomly selected participants, who will receive the conventional treatment for patella fracture.
Device: Traditional Fixation
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 methods for patellar fracture (screws, suture fixation, wire fixation, other plates).
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: Post-op day 1
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.
Time frame: 6 weeks
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.
Time frame: 3 months
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.
Time frame: 6 months
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.
Time frame: 9 months
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.
Time frame: 1 year
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.
Time frame: Post-op day 1
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.
Time frame: 6 weeks
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.
Time frame: 3 months
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.
Time frame: 6 months
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.
Time frame: 9 months
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.
Time frame: 1 year
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).
Time frame: 6 weeks
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).
Time frame: 3 months
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).
Time frame: 6 months
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).
Time frame: 9 months
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).
Time frame: 1 year
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.
Time frame: 6 weeks
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.
Time frame: 3 months
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.
Time frame: 6 months
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.
Time frame: 9 months
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.
Time frame: 1 year
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.
Time frame: 3 months
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.
Time frame: 6 months
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.
Time frame: 9 months
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.
Time frame: 1 year
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.
Time frame: 3 months
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.
Time frame: 6 months
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.
Time frame: 9 months
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.
Time frame: 1 year
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Hartford Hospital