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NCT05765266 | RECRUITING | Knee Osteoarthritis

ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial
Sponsor:

Arthrex, Inc.

Brief Summary:

This study is a prospective, multicenter (up to 4 sites), randomized, double-blind, two-arm study. Forty-five (45) patients will be randomized to receive a single 4-6 ml intra-articular (IA) injection of either the output of ACP Max™ (n=30) or 6 ml of Depo-Medrol® (methylprednisolone acetate) (n=15).

Condition or disease

Knee Osteoarthritis

Intervention/treatment

ACP Max™

Depo-Medrol®

Phase

NA

Detailed Description:

All subjects will have a screening visit and a treatment visit followed by six follow-up visits: 10 days, 6 weeks, 3 months, 6 months, 9 months, and 12 months.

Study Type : INTERVENTIONAL
Estimated Enrollment : 45 participants
Masking : DOUBLE
Masking Description : This is a double-blind study where subjects and evaluators are blinded to treatment.
Primary Purpose : TREATMENT
Official Title : ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial
Actual Study Start Date : 2024-05-13
Estimated Primary Completion Date : 2025-05-14
Estimated Study Completion Date : 2026-05-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Subject voluntarily decides to participate and signs the consent form.
  • 2. Subject is ≥ 18 to 75 years of age.
  • 3. Subject presents with symptomatic knee OA despite at least 6 months of one of the following conservative treatments; oral medications, analgesics, and/or anti-inflammatory medications.
  • 4. Subject has documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 12 weeks of screening.
  • 5. Subject has a WOMAC pain score (WOMAC A) of at least 8 out of 20 and at least moderate degree of difficulty (a score of 2) for at least 2 questions on performing daily activities.
  • 6. Subject consents to a washout period of NSAIDs and analgesics 7 days before each study visit (except low-dose aspirin for prevention of cardiovascular disease).
  • 7. Subject has a Body Mass Index ≤ 35 kg/m2
Exclusion Criteria
  • 1. Subject has Grade I or IV in the target knee according to the Kellgren-Lawrence grading scale.
  • 2. Subject has clinically 3+ effusion of the target knee (stroke test grading system).
  • 3. Subject has significant (\> 10°) valgus or varus deformities as evidenced by standard of care x-ray.
  • 4. Subject has received an IA injection of corticosteroids in the target knee within 4 months prior to screening.
  • 5. Subject did not achieve initial pain relief from prior corticosteroid injections.
  • 6. Subject has received an IA injection of HA in the target knee within 6 months prior to screening.
  • 7. Subject has received an IA injection of PRP in the target knee at any time prior to screening.
  • 8. Subject has a history of coagulopathy.
  • 9. Subject has joint pain reflected by a VAS score of \> 35 mm out of 100 mm scale in the contralateral knee at the time of screening.
  • 10. Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months.
  • 11. Subject has an inflammatory disease of either knee other than OA.
  • 12. Subject which, in the investigator's opinion, has an underlying medical condition(s) that could interfere with the evaluation of the outcome.
  • 13. Subject with a positive pregnancy test or breastfeeding.
  • 14. Subject plans to participate in other clinical trials involving medical or surgical intervention in the next 12 months.
  • 15. Subject with any condition (including cognitive impairment) that, in the investigator's opinion, might interfere with the evaluation of the study objectives.
  • 16. Subject has rheumatoid arthritis or gout.
  • 17. Subject has an infection at the affected joint.
  • 18. Subject has a history of major trauma to the target knee within one year.
  • 19. Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
  • 20. Subject requires pain management therapy not related to the target knee (with the exception of acetaminophen).
  • 21. Subject has a known hypersensitivity to Depo-Medrol and its constituents.
ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial

Location Details

NCT05765266

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, North Carolina

The Center for Clinical Research

Winston-Salem, North Carolina, United States, 27103

RECRUITING

United States, Tennessee

AMR Knoxville

Knoxville, Tennessee, United States, 37920

RECRUITING

United States, Virginia

Spectrum Medical, Inc.

Danville, Virginia, United States, 24541