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Completed

NCT Number: NCT02767492

Steroid Injection vs. BioDRestore for Patients With Knee OA

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

BioD Restore

Device

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

kenalog

Drug

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

The Hawkins Foundation

Other

Collaborators

  • Integra LifeSciences Corporation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 10, 2016
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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