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

NCT ID: NCT02295020

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-04-30

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.

Detailed 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.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Treatment Only

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

Group Type: ACTIVE_COMPARATOR

Standard treatment only

Intervention Type: DRUG

Standard treatment such as NSAIDs and injections

Standard Treatment plus Bioskin Ten-7

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

Group Type: EXPERIMENTAL

Standard treatment only

Intervention Type: DRUG

Standard treatment such as NSAIDs and injections

Standard treatment plus Bioskin Ten-7 knee brace

Intervention Type: DEVICE

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

Interventions

Standard treatment only

Standard treatment such as NSAIDs and injections

Intervention Type: DRUG

Standard treatment plus Bioskin Ten-7 knee brace

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

Intervention Type: DEVICE

Other Intervention Names

NSAIDs and injections

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cropper Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vinod Dasa, MD

Role: PRINCIPAL_INVESTIGATOR

LSUHSC-NO, Orthopaedic Department

Other Identifiers

8627

Identifier Type: -

Identifier Source: org_study_id