Steroid Injection vs. BioDRestore for Patients With Knee OA

T

The Hawkins Foundation

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Drug: Kenalog
Device: BioD Restore

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02767492
Pro00048698

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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