NCT02295020

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

June 1, 2016

Enrollment Period

2.9 years

First QC Date

November 17, 2014

Results QC Date

April 8, 2016

Last Update Submit

June 1, 2016

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (13)

  • KOOS - Pain

    Value at 8 weeks - value at day 0

    Week 8- Day 0

  • KOOS - Symptoms

    Value at 8 weeks - value at day 0

    Week 8 - Day 0

  • KOOS - ADL

    Value at 8 weeks - value at day 0

    week 8 - day 0

  • KOOS - Sport/Rec

    Value at 8 weeks - value at day 0

    Week 8 - day 0

  • KOOS - QOL

    Value at 8 weeks - value at day 0

    Week 8 - day 0

  • Synovial Fluid Analysis (IL-6)

    Interleukine 6 in Synovial fluid analysis

    Week 8 - day 0

  • Synovial Fluid Analysis (IL-8)

    Interleukine 8 in Synovial fluid analysis

    Week 8 - day 0

  • Synovial Fluid Analysis (TNF-alpha)

    Tumor necrosis factor - alpha in Synovial fluid analysis

    Week 8 - day 0

  • Synovial Fluid Analysis (MIP - 1alpha)

    Macrophage Inflammatory Proteins - 1alpha

    Week 8 - day 0

  • Synovial Fluid Analysis (MCP - 1)

    Monocyte chemotactic protein-1 - 1

    Week 8 -day 0

  • Oxford Knee Score

    Day 0 and Week 8

  • WOMAC

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

    Day 0 and Week 8

  • Visual Analog Scale

    identifies pain level

    Day 0 and Week 8

Study Arms (2)

Standard Treatment Only

ACTIVE COMPARATOR

Group A will receive standard treatment only such as NSAIDs and injections

Drug: Standard treatment only

Standard Treatment plus Bioskin Ten-7

EXPERIMENTAL

Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.

Drug: Standard treatment onlyDevice: Standard treatment plus Bioskin Ten-7 knee brace

Interventions

Standard treatment onlyDRUG

Standard treatment such as NSAIDs and injections

Also known as: NSAIDs and injections
Standard Treatment OnlyStandard Treatment plus Bioskin Ten-7
Standard treatment plus Bioskin Ten-7 knee braceDEVICE

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

Standard Treatment plus Bioskin Ten-7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Anti-Inflammatory Agents, Non-SteroidalInjections

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsDrug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Dr. Vinod Dasa
Organization
LSUHSC-NO -Orthopaedic Department
vdasa@lsuhsc.edu
(504) 412-1700

Study Officials

  • Vinod Dasa, MD

    LSUHSC-NO, Orthopaedic Department

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 19, 2014

Study Start

May 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 11, 2016

Results First Posted

July 11, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share