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Steroid Injection vs. BioDRestore for Patients With Knee OA

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BioD Restore
Kenalog
Sponsored by
The Hawkins Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Steadman Hawkins Clinic of the Carolinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BioDRestore™

Corticosteroid

Arm Description

BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.

Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.

Outcomes

Primary Outcome Measures

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.
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
Lysholm Knee Score
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)
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)
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.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2016
Last Updated
October 27, 2021
Sponsor
The Hawkins Foundation
Collaborators
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02767492
Brief Title
Steroid Injection vs. BioDRestore for Patients With Knee OA
Official Title
A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hawkins Foundation
Collaborators
Integra LifeSciences Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Siffri, MD
Organizational Affiliation
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steadman Hawkins Clinic of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Steroid Injection vs. BioDRestore for Patients With Knee OA

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