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NCT04655703

Use of the DJO Brace With the Motion Intelligence Platform in the Postoperative Total Knee Arthroplasty Patient

Terminated NA Results posted Last updated 14 November 2022
What this trial tests

NA trial testing DJO X4 brace with Motion Intelligence Platform in Total Knee Replacement in 16 participants. Terminated before completion.

Timeline
28 December 2020
Primary endpoint
17 June 2021
17 June 2021

Quick facts

Lead sponsorNorthwell Health
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment16
Start date28 December 2020
Primary completion17 June 2021
Estimated completion17 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Northwell Health — full company profile →

Who can join

Adults 18 to 90, any sex, with Total Knee Replacement. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Calculated "Knee Society Score" Primary · Preoperatively and 8 weeks postoperatively

Functional outcomes measured by the 2011 "Knee Society Score". The Functional Activities section consists of 4 sub-sections with a total score ranging from 0-100 points. The higher the numerical value the better the outcome. The sub-sections consist of: (1)Walking and Standing 0-30 points (2)Standard Activities 0-30 points (3)Advanced Activities 0-25 points (4)Discretionary Knee Activities 0-15 points.

GroupValue95% CI
Cohort 159.750 – 78
Cohort 260.534 – 83

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Total Knee Replacement

Currently open trials in the same condition.

Other Northwell Health trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04655703.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing