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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

Summary

This trial aims to see if using the Guardian knee brace can help patients with limited knee movement. The brace supports the knee, which may improve recovery and reduce complications.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,397 Previous Clinical Trials
861,842 Total Patients Enrolled
17 Trials studying Osteoarthritis
4,113 Patients Enrolled for Osteoarthritis
Morteza Meftah, MDPrincipal InvestigatorNYU Langone Health
~0 spots leftby Sep 2025
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