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DJO X4 Brace with Motion Intelligence Platform: Discharge to rehabilitation center for Total Knee Arthroplasty

N/A
Waitlist Available
Led By Eugene S Krauss, MD
Research Sponsored by Northwell 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 preoperatively and 8 weeks postoperatively
Awards & highlights

Summary

This is a single center, investigator initiated clinical trial using a FDA approved, marketed brace called DJO X4. This phase 4, prospective, randomized clinical trial is being conducted to evaluate the use of the X4 knee brace with the Motion Intelligence platform in patients having unilateral TKA. The study is designed to determine if using a "virtual rehabilitation" device leads to enhanced recovery following TKA by improving patient objective and subjective outcome measures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperatively and 8 weeks postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperatively and 8 weeks postoperatively 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 the Calculated "Knee Society Score"

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: DJO X4 Brace with Motion Intelligence Platform: Home dischargeExperimental Treatment1 Intervention
Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform.
Group II: DJO X4 Brace with Motion Intelligence Platform: Discharge to rehabilitation centerExperimental Treatment1 Intervention
Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform.
Group III: Control group: Discharge to rehabilitation centerActive Control1 Intervention
Patients randomized to this group will serve as the control group. There will be no changes to the standard of care recovery for a TKA patient.
Group IV: Control group: Home dischargeActive Control1 Intervention
Patients randomized to this group will serve as the control group. There will be no changes to the standard of care recovery for a TKA patient.

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Who is running the clinical trial?

Northwell HealthLead Sponsor
461 Previous Clinical Trials
471,119 Total Patients Enrolled
Eugene S Krauss, MDPrincipal InvestigatorNorthwell Health System
~3 spots leftby Sep 2025
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