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Procedure

LCP Patella Plating System vs Traditional Fixation for Knee Fracture

N/A

Waitlist Available

Research Sponsored by Hartford Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will compare how well the Depuy Synthes LCP Variable Angle Plating System works to fix broken patellas compared to traditional methods.

Who is the study for?

This trial is for men and women aged 18-74 who have a broken kneecap and are being treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital. It's not for those over 75, non-walkers before injury, with previous patellar fractures, knee arthritis, or other leg bone fractures.Check my eligibility

What is being tested?

The study compares the DePuy Synthes LCP Variable Angle Patella Plating System to traditional methods of fixing a broken kneecap. Participants will be randomly assigned to one of the treatments and followed up with surveys, x-rays, range of motion tests, as well as strength and balance assessments over a year.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include pain at the fracture site, infection from surgery, issues with bone healing like nonunion or malunion (where bones don't heal properly), irritation from hardware placed in the knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison

DePuy Synthes LCP Variable Angle Patella Plating System functional outcomes comparison

DePuy Synthes LCP Variable Angle Patella Plating System patient reported outcomes comparison

Secondary outcome measures

Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)

Balance

Passive Range of Motion (ROM)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Depuy Synthes LCP Patella Plating SystemExperimental Treatment1 Intervention

This group will have 18 randomly selected participants, who will receive the Depuy Synthes LCP Patella Plating System for patella fracture.

Group II: Control/Conventional FixationExperimental Treatment1 Intervention

This group will have 18 randomly selected participants, who will receive the conventional treatment for patella fracture.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor

133 Previous Clinical Trials

18,896 Total Patients Enrolled

Media Library

Traditional Fixation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05824676 — N/A

Knee Fracture Research Study Groups: Depuy Synthes LCP Patella Plating System, Control/Conventional Fixation

Knee Fracture Clinical Trial 2023: Traditional Fixation Highlights & Side Effects. Trial Name: NCT05824676 — N/A

Traditional Fixation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05824676 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research necessitate that participants be over 65 years of age?

"Compliance with the ineligibility standards of this experiment necessitates that participants are at least 18 years old but not beyond 74."

Answered by AI

Are there any remaining spots open for participation in this investigation?

"Per information on clinicaltrials.gov, no further recruitment is needed for this study as of April 10th 2023; the trial was initially posted on May 1st 2023. However, 421 other trials are currently in need of participants at present."

Answered by AI

What kind of patient profile is best suited for this experimental program?

"Eligibility for this medical trial requires a patient to have knee pain and be between 18 and 74 years old. An aggregate of 36 patients are accepted into the study."

Answered by AI

What aims are being pursued through this research endeavor?

"This clinical trial's primary objective, assessed over a year-long period of time, is to compare the efficacy of DePuy Synthes LCP Variable Angle Patella Plating System. Subsidiary outcomes include ADL-KOS (Activities of Daily Living - Knee Outcomes Survey), Radiographs and Passive Range Of Motion (ROM). The former involves 14 questions evaluating the functional ability related to their knee and how symptoms may influence day-to-day activities; it scores 0 to 100 with zero representing no capability and hundred attaining maximum efficiency. X Rays will be taken at each visit starting from week 6 for"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DePuy Synthes Variable Angle LCP Patella Plating System Study

Michael Miranda 2023. "DePuy Synthes Variable Angle LCP Patella Plating System Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05824676.

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