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TraumaNCT05824676

DePuy Synthes Variable Angle LCP Patella Plating System Study

A study testing Variable Angle LCP Patella Plating System and Traditional Fixation in people with Trauma and Patella Fracture, run by Hartford Hospital at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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). Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Trauma, Patella Fracture, Knee Cap
What is being tested?
Variable Angle LCP Patella Plating System and Traditional Fixation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
May 2023to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jake R Corsa, Bsc contact

860-972-6685

Jake.Corsa@hhchealth.org

Bethany Samperi, Bsc contact

860-972-5978

Bethany.Samperi@hhchealth.org

United States1 site
  • Hartford HealthCare The Bone and Joint Institute

    Hartford, Connecticut, 06106

    Jake R Corsa, BSc, 860-972-6685, Jake.Corsa@hhchealth.org

    Bethany Samperi, BSc, 860-972-5978, Bethany.Samperi@hhchealth.org

Other trials in United States

About this study

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

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:

Read more
  • 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.
Being tested
Variable Angle LCP Patella Plating System, Traditional Fixation
Keywords
Patella, Plating, trauma, kneecap, injury, knee injuries, knee injury, fracture, break, randomized
Medical subject headings
Wounds and Injuries, Patella Fracture, Knee Injuries, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Variable Angle LCP Patella Plating SystemDevice

    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 FixationDevice

    Traditional fixation methods for patellar fracture (screws, suture fixation, wire fixation, other plates).

Study groups in NCT05824676
Study groupRoleWhat they receive
Depuy Synthes LCP Patella Plating SystemExperimentalThis group will have 18 randomly selected participants, who will receive the Depuy Synthes LCP Patella Plating System for patella fracture.
Receives: Device: Variable Angle LCP Patella Plating System
Control/Conventional FixationOtherThis group will have 18 randomly selected participants, who will receive the conventional treatment for patella fracture.
Receives: Device: Traditional Fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. 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.

    Measured: 1 year

Secondary outcomes (30)
  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.

    Measured: Post-op day 1

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 9 months

  6. 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.

    Measured: 1 year

  7. 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.

    Measured: Post-op day 1

  8. 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.

    Measured: 6 weeks

  9. 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.

    Measured: 3 months

  10. 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.

    Measured: 6 months

  11. 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.

    Measured: 9 months

  12. 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.

    Measured: 1 year

  13. 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).

    Measured: 6 weeks

  14. 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).

    Measured: 3 months

  15. 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).

    Measured: 6 months

  16. 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).

    Measured: 9 months

  17. 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).

    Measured: 1 year

  18. 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.

    Measured: 6 weeks

  19. 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.

    Measured: 3 months

  20. 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.

    Measured: 6 months

  21. 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.

    Measured: 9 months

  22. 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.

    Measured: 1 year

  23. 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.

    Measured: 3 months

  24. 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.

    Measured: 6 months

  25. 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.

    Measured: 9 months

  26. 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.

    Measured: 1 year

  27. 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.

    Measured: 3 months

  28. 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.

    Measured: 6 months

  29. 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.

    Measured: 9 months

  30. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2023
  2. Study startMay 2023 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05824676
Sponsor's protocol ID
HHC-2022-0283
Status last verified
Feb 2023
First submitted
1 Mar 2023
Last updated
21 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Variable Angle LCP Patella Plating System and Traditional Fixation in people with Trauma and Patella Fracture, run by Hartford Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jake R Corsa, Bsc (860-972-6685, Jake.Corsa@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.

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