Bioskin Cytokine Study

Osteoarthritis of the Knee Clinical Trial

— Bioskin  

Official title:

Bioskin Cytokine Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295020
• Other study ID #: 8627
• Status: Completed
• Phase: N/A
• First received: November 17, 2014
• Last updated: April 6, 2016
• Start date: May 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Cropper Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Once consented, the patient is assigned to either Group A or Group B. Group A patients will receive standard treatment only and will not be prescribed a knee brace. Group B patients will receive standard treatment and the Bioskin Ten-7 knee brace. On Day 0, the patient will be assigned to one of the 2 groups using a 1:1 assignment. VAS, WOMAC, Oxford Knee Score, KOOS questionnaires will be administered and a sample of the patient's synovial fluid will be sent to labs for cytokine and cell count analysis. All patients will record use of NSAIDs and for Group B, the start and end time of brace use will be recorded. All patients will return in 8 weeks to assess efficacy of treatment. All patients will return their diaries, complete the same validated outcome measures as Day 0 and undergo a repeat synovial fluid analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Standard treatment with NSAIDs

Device:
• Bioskin Ten-7 knee brace

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cropper Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	identifies pain level	Day 0 and Week 8	No
Primary	Western Ontario and McMaster universities Osteoarthritis Index (WOMAC)	assess pain, stiffness, and physical function	Day 0 and Week 8	No
Primary	Oxford Knee Score		Day 0 and Week 8	No
Primary	KOOS		Day 0 and Week 8	No
Primary	Synovial fluid analysis		Day 0 and Week 8	No