An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee

Phase 4

Withdrawn

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Acellular amniotic membrane derived allograft injection (NuDYN)

• Registration Number: NCT04201743
• Lead Sponsor: Illinois Center for Orthopaedic Research and Education

Brief Summary

The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft injection for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection.

Detailed Description

It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL).

60 subjects will be enrolled in this study. Subjects will be randomized 1:1 in treatment arms.

Each of the patient will be treated with one time injection to the knee. Methods for collecting data will be through validated patient-reported outcome tools (KOOS, VAS and WOMAC questionnaire) that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.

Study Timeline

• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2019-12-14
• Study First Posted: 2019-12-17
• Study Start: 2020-03-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-05
• Primary Completion: 2021-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age of 21 to 80 years
• Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale

Exclusion Criteria

• Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale

• BMI greater than 40 kg/m2

• Subject has active infection at the injection site

• Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy.

• Subject has rheumatoid arthritis, psoriatic arthritis or has been diagnosed with any other disorder that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor or cancer

• Subject has documented history of gout or pseudo-gout

• Subject has an autoimmune disease or known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV

• Subject has received any of the following to the target knee:

  1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
  2. Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment
  3. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
  4. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment

• History of partial or total knee arthroplasty

• Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment

• Subject has a history of immunosuppressive or chemotherapy in the last 5 years

• Subject has had prior radiation at the site

• Subject is currently taking narcotic medication for any reason.

• Subject is pregnant or plans to become pregnant within 365 days of treatment

• Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation

• Subject is a worker's compensation patient

• Subject is a prisoner

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 mL NyDYN injection	Acellular amniotic membrane derived allograft injection (NuDYN)	30 patients (out of 60) will be doubled blinded randomized to this arm and get 1 mL NyDYN injection.
2 mL NyDYN injection	Acellular amniotic membrane derived allograft injection (NuDYN)	30 patients (out of 60) will be doubled blinded randomized to this arm and get 2 mL NyDYN injection.

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires	180 days	Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

Secondary Outcome Measures

Name	Time	Method
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires	90, 180 and 365 days	Change from baseline Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

Trial Locations

Locations (1)

Hinsdale Orthopaedic Associates; 🇺🇸 Westmont, Illinois, United States