Osteoarthritis of the KneeBioskinNCT02295020
Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
A study testing Standard treatment only and Standard treatment plus Bioskin Ten-7 knee brace in people with Osteoarthritis of the Knee, run by Cropper Medical.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Standard treatment only and Standard treatment plus Bioskin Ten-7 knee brace
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years and older with primary diagnosis of Knee OA with no other knee diagnosis.
- Must have telephone access.
Who cannot join
- -
About this study
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.
Read the 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
- Being tested
- Standard treatment only, Standard treatment plus Bioskin Ten-7 knee brace
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatment onlyDrug
Also called NSAIDs and injections
Standard treatment such as NSAIDs and injections
Standard treatment plus Bioskin Ten-7 knee braceDevice
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment Only | Active comparator | Group A will receive standard treatment only such as NSAIDs and injections Receives: 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. Receives: Drug: Standard treatment only; Device: Standard treatment plus Bioskin Ten-7 knee brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS - Pain
Value at 8 weeks - value at day 0
Measured: Week 8- Day 0
KOOS - Symptoms
Value at 8 weeks - value at day 0
Measured: Week 8 - Day 0
KOOS - ADL
Value at 8 weeks - value at day 0
Measured: week 8 - day 0
KOOS - Sport/Rec
Value at 8 weeks - value at day 0
Measured: Week 8 - day 0
KOOS - QOL
Value at 8 weeks - value at day 0
Measured: Week 8 - day 0
Synovial Fluid Analysis (IL-6)
Interleukine 6 in Synovial fluid analysis
Measured: Week 8 - day 0
Synovial Fluid Analysis (IL-8)
Interleukine 8 in Synovial fluid analysis
Measured: Week 8 - day 0
Synovial Fluid Analysis (TNF-alpha)
Tumor necrosis factor - alpha in Synovial fluid analysis
Measured: Week 8 - day 0
Synovial Fluid Analysis (MIP - 1alpha)
Macrophage Inflammatory Proteins - 1alpha
Measured: Week 8 - day 0
Synovial Fluid Analysis (MCP - 1)
Monocyte chemotactic protein-1 - 1
Measured: Week 8 -day 0
Oxford Knee Score
Measured: Day 0 and Week 8
WOMAC
assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index
Measured: Day 0 and Week 8
Visual Analog Scale
identifies pain level
Measured: Day 0 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startMay 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cropper Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinod Dasa, MD, Principal investigator, LSUHSC-NO, Orthopaedic Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295020
- Sponsor's protocol ID
- 8627
- Acronym
- Bioskin
- Status last verified
- Jun 2016
- First submitted
- 17 Nov 2014
- Last updated
- 11 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
- ClinicalTrials.gov ID
- NCT02295020
- Acronym / sponsor ID
- Bioskin / 8627
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cropper MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Posted 11 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment Only | Active comparator | Drug: Standard treatment onlyGroup A will receive standard treatment only such as NSAIDs and injections |
| Standard Treatment plus Bioskin Ten-7 | Experimental | Drug: Standard treatment only, Device: Standard treatment plus Bioskin Ten-7 knee braceGroup B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female 18 years and older with primary diagnosis of Knee OA with no other knee diagnosis.
- Must have telephone access.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatment onlyAlso: NSAIDs and injectionsStandard treatment such as NSAIDs and injections | Drug | Standard Treatment Only, Standard Treatment plus Bioskin Ten-7 |
| Standard treatment plus Bioskin Ten-7 knee braceStandard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace. | Device | Standard Treatment plus Bioskin Ten-7 |
Primary outcome
KOOS - Pain
Time frame: Week 8- Day 0
Value at 8 weeks - value at day 0
KOOS - Symptoms
Time frame: Week 8 - Day 0
Value at 8 weeks - value at day 0
KOOS - ADL
Time frame: week 8 - day 0
Value at 8 weeks - value at day 0
KOOS - Sport/Rec
Time frame: Week 8 - day 0
Value at 8 weeks - value at day 0
KOOS - QOL
Time frame: Week 8 - day 0
Value at 8 weeks - value at day 0
Synovial Fluid Analysis (IL-6)
Time frame: Week 8 - day 0
Interleukine 6 in Synovial fluid analysis
Synovial Fluid Analysis (IL-8)
Time frame: Week 8 - day 0
Interleukine 8 in Synovial fluid analysis
Synovial Fluid Analysis (TNF-alpha)
Time frame: Week 8 - day 0
Tumor necrosis factor - alpha in Synovial fluid analysis
Synovial Fluid Analysis (MIP - 1alpha)
Time frame: Week 8 - day 0
Macrophage Inflammatory Proteins - 1alpha
Synovial Fluid Analysis (MCP - 1)
Time frame: Week 8 -day 0
Monocyte chemotactic protein-1 - 1
Oxford Knee Score
Time frame: Day 0 and Week 8
WOMAC
Time frame: Day 0 and Week 8
assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index
Visual Analog Scale
Time frame: Day 0 and Week 8
identifies pain level
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinod Dasa, MD principal investigator
LSUHSC-NO, Orthopaedic Department
Questions about this trial
What is this clinical trial studying?
A study testing Standard treatment only and Standard treatment plus Bioskin Ten-7 knee brace in people with Osteoarthritis of the Knee, run by Cropper Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS - Pain (time frame: Week 8- Day 0). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.