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OpenTrials
Completed

NCT Number: NCT02295020

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Standard treatment only

Drug

Standard treatment such as NSAIDs and injections

Other names: NSAIDs and injections

Standard treatment plus Bioskin Ten-7 knee brace

Device

Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.

Primary outcomes

  1. KOOS - Pain

    Time frame: Week 8- Day 0

    Value at 8 weeks - value at day 0

  2. KOOS - Symptoms

    Time frame: Week 8 - Day 0

    Value at 8 weeks - value at day 0

  3. KOOS - ADL

    Time frame: week 8 - day 0

    Value at 8 weeks - value at day 0

  4. KOOS - Sport/Rec

    Time frame: Week 8 - day 0

    Value at 8 weeks - value at day 0

  5. KOOS - QOL

    Time frame: Week 8 - day 0

    Value at 8 weeks - value at day 0

  6. Synovial Fluid Analysis (IL-6)

    Time frame: Week 8 - day 0

    Interleukine 6 in Synovial fluid analysis

  7. Synovial Fluid Analysis (IL-8)

    Time frame: Week 8 - day 0

    Interleukine 8 in Synovial fluid analysis

  8. Synovial Fluid Analysis (TNF-alpha)

    Time frame: Week 8 - day 0

    Tumor necrosis factor - alpha in Synovial fluid analysis

  9. Synovial Fluid Analysis (MIP - 1alpha)

    Time frame: Week 8 - day 0

    Macrophage Inflammatory Proteins - 1alpha

  10. Synovial Fluid Analysis (MCP - 1)

    Time frame: Week 8 -day 0

    Monocyte chemotactic protein-1 - 1

  11. Oxford Knee Score

    Time frame: Day 0 and Week 8

  12. WOMAC

    Time frame: Day 0 and Week 8

    assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index

  13. Visual Analog Scale

    Time frame: Day 0 and Week 8

    identifies pain level

Sponsors and collaborators

Lead sponsor

Cropper Medical

Industry

Registry information

Acronym: Bioskin

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 19, 2014
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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