Steroid Injection vs. BioDRestore for Patients With Knee OA

• Sponsor: The Hawkins Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT02767492
• Collaborator: Integra LifeSciences Corporation (Industry)
• Enrollment: 90
• Location: 1
• Arms: 2
• Actual Duration (Months): 36
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Device: BioD Restore; Drug: Kenalog	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BioDRestore™ BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.	Device: BioD Restore; Investigational product, BioD Restore, will be injected into the articular space of the knee.
Active Comparator: Corticosteroid Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.	Drug: Kenalog; Active comparator, Kenalog steroid, will be injected into the articular space of the knee.

Outcome Measures

Primary Outcome Measures

1. Visual Analog Pain Score [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.

2. Veterans Rand 12 Item Health Survey [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

3. Lysholm Knee Score [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.

4. Single Alpha Numeric Evaluation (SANE) [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.

5. Knee Injury and Osteoarthritis Outcome Score (KOOS) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Steadman Hawkins Clinic of the Carolinas	Greenville	South Carolina	United States	29615

Sponsors and Collaborators

• The Hawkins Foundation
• Integra LifeSciences Corporation

Investigators

• Principal Investigator: Paul Siffri, MD, Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 5, 2017

More Information

Publications

None provided.

• Responsible Party: The Hawkins Foundation
• ClinicalTrials.gov Identifier: NCT02767492
• Other Study ID Numbers: Pro00048698
• First Posted: May 10, 2016
• Last Update Posted: Nov 23, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Triamcinolone Acetonide

Study Results

Participant Flow

Arm/Group Title	BioDRestore™	Corticosteroid
Arm/Group Description	BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.	Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
Period Title: Overall Study
STARTED	45	45
COMPLETED	35	35
NOT COMPLETED	10	10

Baseline Characteristics

Arm/Group Title	BioDRestore™	Corticosteroid	Total
Arm/Group Description	BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.	Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.	Total of all reporting groups
Overall Participants	45	45	90
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 62.2%	29 64.4%	57 63.3%
>=65 years	17 37.8%	16 35.6%	33 36.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.86 (8.98)	64.03 (8.92)	62.92 (8.96)
Sex: Female, Male (Count of Participants)
Female	28 62.2%	25 55.6%	53 58.9%
Male	17 37.8%	20 44.4%	37 41.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 2.2%	1 1.1%
Not Hispanic or Latino	44 97.8%	44 97.8%	88 97.8%
Unknown or Not Reported	1 2.2%	0 0%	1 1.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 2.2%	3 6.7%	4 4.4%
White	43 95.6%	42 93.3%	85 94.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 2.2%	0 0%	1 1.1%
Region of Enrollment (participants) [Number]
United States	45 100%	45 100%	90 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Pain Score
Description	Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain.
Time Frame	Surgery through 12 months post-op/

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BioDRestore™	Corticosteroid
Arm/Group Description	BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.	Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
Measure Participants	35	35
Mean (Standard Deviation) [score on a scale]	2.49 (2.41)	3.25 (2.82)

2. Primary Outcome

Title	Veterans Rand 12 Item Health Survey
Description	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
Time Frame	Sugery to 12 months post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BioDRestore™	Corticosteroid
Arm/Group Description	BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.	Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
Measure Participants	35	35
Mean (Standard Deviation) [score on a scale]	56.95 (9.84)	58.01 (7.49)

3. Primary Outcome

Title	Lysholm Knee Score
Description	Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms.
Time Frame	Surgery to 12 months post-op.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BioDRestore™	Corticosteroid
Arm/Group Description	BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.	Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
Measure Participants	35	35
Mean (Standard Deviation) [score on a scale]	75.26 (17.75)	61.00 (22.00)

4. Primary Outcome

Title	Single Alpha Numeric Evaluation (SANE)
Description	Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly "normal" knee and 0 being a completely "abnormal" knee.
Time Frame	Surgery to 12 months post-op.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BioDRestore™	Corticosteroid
Arm/Group Description	BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.	Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
Measure Participants	35	35
Mean (Standard Deviation) [score on a scale]	66.14 (23.27)	60.49 (25.37)

5. Primary Outcome

Title	Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description	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.
Time Frame	Surgery to 12 months post op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BioDRestore™	Corticosteroid
Arm/Group Description	BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.	Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
Measure Participants	35	35
Mean (Standard Deviation) [score on a scale]	64.10 (21.23)	55.67 (22.23)

Adverse Events

Time Frame	12 months
Arm/Group Title	BioDRestore™		Corticosteroid
Arm/Group Description	BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee.		Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
All Cause Mortality
	BioDRestore™		Corticosteroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Serious Adverse Events
	BioDRestore™		Corticosteroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	BioDRestore™		Corticosteroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.