Knee OsteoarthritisNCT02767492
Steroid Injection vs. BioDRestore for Patients With Knee OA
A study testing BioD Restore and Kenalog in people with Knee Osteoarthritis, run by The Hawkins Foundation at 1 site in United States.
Trial summary
This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- BioD Restore and Kenalog
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jan 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 80 years.
- Willing and able to give voluntary informed consent to participate in this investigation.
- Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA diagnosed and confirmed by treating physician using standing x-ray).
- Candidate for intra-articular knee injection.
- BMI < 40
Who cannot join
- Patients who have received intra-articular injection(s) in the last 3 months.
- Patients who have undergone arthroscopic surgery on the study knee in the past year.
- Patients who have undergone arthroplasty on the study knee.
- Ligament instability
- Diabetes (Type 1 or II)
- Inflammatory arthropathies.
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- Fibromyalgia or chronic fatigue syndrome.
- Female patient who is pregnant or nursing.
- Chronic use of narcotics.
- Any other reason (in the judgment of the investigator).
Trial locations and contacts
1 site in 1 country.
United States1 site
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29615
About this study
Official title: A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis
This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.
- Conditions
- Knee Osteoarthritis
- Being tested
- BioD Restore, Kenalog
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioD RestoreDevice
Investigational product, BioD Restore, will be injected into the articular space of the knee.
KenalogDrug
Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
| Study group | Role | What they receive |
|---|---|---|
| BioDRestore™ | Experimental | BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. Receives: Device: BioD Restore |
| Corticosteroid | Active comparator | Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. Receives: Drug: Kenalog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Score
Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain.
Measured: Surgery through 12 months post-op/
Veterans Rand 12 Item Health Survey
Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores
Measured: Sugery to 12 months post-op
Lysholm Knee Score
Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms.
Measured: Surgery to 12 months post-op.
Single Alpha Numeric Evaluation (SANE)
Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly "normal" knee and 0 being a completely "abnormal" knee.
Measured: Surgery to 12 months post-op.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS) on a scale of 0 to 100. The higher score of 100 indicates a fully functional knee without knee pain or problems.
Measured: Surgery to 12 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2020
- Study completionJan 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Sponsor
- Investigators
- Paul Siffri, MD, Principal investigator, Steadman Hawkins Clinic of the Carolinas - Greenville Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767492
- Sponsor's protocol ID
- Pro00048698
- Status last verified
- Oct 2021
- First submitted
- 5 May 2016
- Last updated
- 23 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pill SG, Ahearn B, Tokish JM, Cook C, Siffri PJ, Mercuri JJ, Burnikel B, Cassas KJ, Wyland DJ, Sawvell E, Wright N, Hutchinson J, Bynarowicz T, Adams KJ, Kissenberth MJ. Amniotic Tissue Injections Are an Effective Alternative to Corticosteroid Injections for Pain Relief and Function in Patients With Severe Knee Osteoarthritis: A Double-Blind, Randomized, Prospective Study. J Am Acad Orthop Surg Glob Res Rev. 2025 Jan 9;9(1):e23.00276. doi: 10.5435/JAAOSGlobal-D-23-00276. eCollection 2025 Jan 1.
PubMed 39813395
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02767492
- Acronym / sponsor ID
- Pro00048698
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Posted 23 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioDRestore™ | Experimental | Device: BioD RestoreBioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. |
| Corticosteroid | Active comparator | Drug: KenalogKenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 18 to 80 years.
- Willing and able to give voluntary informed consent to participate in this investigation.
- Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA diagnosed and confirmed by treating physician using standing x-ray).
- Candidate for intra-articular knee injection.
- BMI < 40
Key exclusion criteria (10 listed)
- Patients who have received intra-articular injection(s) in the last 3 months.
- Patients who have undergone arthroscopic surgery on the study knee in the past year.
- Patients who have undergone arthroplasty on the study knee.
- Ligament instability
- Diabetes (Type 1 or II)
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 |
|---|---|---|
| BioD RestoreInvestigational product, BioD Restore, will be injected into the articular space of the knee. | Device | BioDRestore™ |
| KenalogActive comparator, Kenalog steroid, will be injected into the articular space of the knee. | Drug | Corticosteroid |
Primary outcome
Visual Analog Pain Score
Time frame: Surgery through 12 months post-op/
Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain.
Veterans Rand 12 Item Health Survey
Time frame: Sugery to 12 months post-op
Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores
Lysholm Knee Score
Time frame: Surgery to 12 months post-op.
Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms.
Single Alpha Numeric Evaluation (SANE)
Time frame: Surgery to 12 months post-op.
Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly "normal" knee and 0 being a completely "abnormal" knee.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Surgery to 12 months post op
Knee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS) on a scale of 0 to 100. The higher score of 100 indicates a fully functional knee without knee pain or problems.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39813395Pill SG, Ahearn B, Tokish JM, Cook C, Siffri PJ, Mercuri JJ, Burnikel B, Cassas KJ, Wyland DJ, Sawvell E, Wright N, Hutchinson J, Bynarowicz T, Adams KJ, Kissenberth MJ. Amniotic Tissue Injections Are an Effective Alternative to Corticosteroid Injections for Pain Relief and Function in Patients With Severe Knee Osteoarthritis: A Double-Blind, Randomized, Prospective Study. J Am Acad Orthop Surg Glob Res Rev. 2025 Jan 9;9(1):e23.00276. doi: 10.5435/JAAOSGlobal-D-23-00276. eCollection 2025 Jan 1.
- 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.
Paul Siffri, MD principal investigator
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioD Restore and Kenalog in people with Knee Osteoarthritis, run by The Hawkins Foundation at 1 site in United States.
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 5 inclusion and 10 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 23 Nov 2021). 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?
Visual Analog Pain Score (time frame: Surgery through 12 months post-op/). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02767492, which also lists 1 linked publication.
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 23 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.