N/A Completed N=40 Randomized Treatment

Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.

Knee Osteoarthritis

Source: ClinicalTrials.gov NCT02295020 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Jul 2016

Primary outcomePrimary: KOOS - Pain — 17.6; 9.1 units on a scale — p=0.181

Summary

The objectives of the study are 1.) to evaluate pain relief following the application of the Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more effective at reducing inflammation than standard of care alone using synovial fluid cytokine analysis and validated outcome measures.

Outcome Measures

Outcome	Result	p-value
PRIMARY KOOS - Pain	17.6; 9.1	0.181
PRIMARY KOOS - Symptoms	10.6; 3.2	0.232
PRIMARY KOOS - ADL	15.3; 9.8	0.311
PRIMARY KOOS - Sport/Rec	13.8; 9.6	—
PRIMARY KOOS - QOL	11.0; 5.4	0.449
PRIMARY Synovial Fluid Analysis (IL-6)	-453.8; -1055	0.860
PRIMARY Synovial Fluid Analysis (IL-8)	-379.8; -488.9	0.735
PRIMARY Synovial Fluid Analysis (TNF-alpha)	-97.4; -51.7	0.479
PRIMARY Synovial Fluid Analysis (MIP - 1alpha)	-246.7; -49.8	0.323
PRIMARY Synovial Fluid Analysis (MCP - 1)	-7170; -4890	0.878
PRIMARY Oxford Knee Score	—	—
PRIMARY WOMAC	—	—
PRIMARY Visual Analog Scale	—	—

Eligibility Criteria

Inclusion Criteria

Male or female 18 years and older with primary diagnosis of Knee OA with no other knee diagnosis.
Must have telephone access.

Exclusion Criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02295020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.