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.
Group
Value
95% CI
Cohort 1
59.7
50 – 78
Cohort 2
60.5
34 – 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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Sponsor: as reported to ClinicalTrials.gov by Northwell Health
Last refreshed: 14 November 2022
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.