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Guardian Sport Rehabilitator knee brace for Osteoarthritis

N/A
Waitlist Available
Led By Morteza Meftah, MD
Research Sponsored by NYU Langone Health
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 visit 1( 1 week pre surgery), visit 2 (2 weeks post surgery) , visit 3 (6 weeks post surgery), visit 4 ( 12 weeks post surgery)
Awards & highlights

Study Summary

This trial will test if using a Guardian brace during pre-surgery and post-surgery rehab can help improve outcomes and reduce the incidence of post-operative flexion contractures, which can reduce knee range of motion.

Eligible Conditions
  • Osteoarthritis of the Knee

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1( 1 week pre surgery), visit 2 (2 weeks post surgery) , visit 3 (6 weeks post surgery), visit 4 ( 12 weeks post surgery)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1( 1 week pre surgery), visit 2 (2 weeks post surgery) , visit 3 (6 weeks post surgery), visit 4 ( 12 weeks post surgery) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in extensor leg strength
Change in flexor leg strength
Change in range of motion following knee replacement surgery

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Guardian knee brace groupExperimental Treatment1 Intervention
Patients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy. Those randomized to this group will be fitted with a Guardian Rehabilitator Brace.
Group II: No Guardian brace used groupActive Control1 Intervention
Patients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy as part of standard of care.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,726 Total Patients Enrolled
17 Trials studying Osteoarthritis
4,125 Patients Enrolled for Osteoarthritis
Morteza Meftah, MDPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

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

Is there any availability for potential participants to join this clinical trial?

"According to clinicaltrials.gov, this medical research project is actively recruiting volunteers having gone live on February 7th 2022 with the most recent update occurring in August 5th of the same year."

Answered by AI

How many people are taking part in this investigation?

"Affirmative. According to clinicaltrials.gov, the research was first advertised on February 7th 2022 and is still actively recruiting participants. This trial requires 56 volunteers from a single site."

Answered by AI

Who meets the criteria for participating in this investigation?

"This investigation will accept 56 participants aged 18-90, all of whom suffer from osteoarthritis in their knee. To qualify for the trial, patients must be consenting adults and surgical candidates with a pre-operative flexion contracture of 10 degrees or more who agree to adhere to study protocol and comply with scheduled visits."

Answered by AI

Is geriatric participation acceptable in this research endeavor?

"Participants of this medical trial must be over 18 years old and not exceeding 90 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Utilization of a Knee Brace With Extension Swing
2022. "Utilization of a Knee Brace With Extension Swing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05179044.
~0 spots leftby Apr 2025
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