Guardian Sport Rehabilitator knee brace for Osteoarthritis of the Knee

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Osteoarthritis of the KneeGuardian Sport Rehabilitator knee brace - Device
Eligibility
18 - 90
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Isometric knee extensor test
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Immediate 8-Week SOAR Program
1
Tri-Compartment Unloader Brace

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)

Week 12
Change in extensor leg strength
Change in flexor leg strength
Change in range of motion following knee replacement surgery

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Isometric knee extensor test
1
Immediate 8-Week SOAR Program
1
Tri-Compartment Unloader Brace

Trial Design

2 Treatment Groups

No Guardian brace used group
1 of 2
Guardian knee brace group
1 of 2

Active Control

Experimental Treatment

56 Total Participants · 2 Treatment Groups

Primary Treatment: Guardian Sport Rehabilitator knee brace · No Placebo Group · N/A

Guardian knee brace group
Device
Experimental Group · 1 Intervention: Guardian Sport Rehabilitator knee brace · Intervention Types: Device
No Guardian brace used groupNoIntervention Group · 1 Intervention: No Guardian brace used group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: visit 1( 1 week pre surgery), visit 2 (2 weeks post surgery) , visit 3 (6 weeks post surgery), visit 4 ( 12 weeks post surgery)

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,263 Previous Clinical Trials
753,249 Total Patients Enrolled
3 Trials studying Osteoarthritis of the Knee
377 Patients Enrolled for Osteoarthritis of the Knee
Morteza Meftah, MDPrincipal InvestigatorNYU Langone Health

Eligibility Criteria

Age 18 - 90 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a pre-operative flexion contracture of 10 degrees or greater.
References

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