Steroid Injection vs. BioDRestore for Patients With Knee OA

Knee Osteoarthritis Clinical Trial

Official title:

A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767492
• Other study ID #: Pro00048698
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: October 2021
• Source: The Hawkins Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• BioD Restore
Investigational product, BioD Restore, will be injected into the articular space of the knee.

Drug:
• Kenalog
Active comparator, Kenalog steroid, will be injected into the articular space of the knee.

Locations

Country	Name	City	State
United States	Steadman Hawkins Clinic of the Carolinas	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
The Hawkins Foundation	Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Surgery through 12 months post-op/
Primary	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	Sugery to 12 months post-op
Primary	Lysholm Knee Score	Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms.	Surgery to 12 months post-op.
Primary	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.	Surgery to 12 months post-op.
Primary	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.	Surgery to 12 months post op