APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA) (PROGRESS II)

Zimmer Biomet

Status

Completed

Conditions

Osteoarthritis, Knee

Treatments

Device: Saline

Device: APS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02138890

BBI.CR.APS1.14

Details and patient eligibility

About

This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with osteoarthritis (OA) of the knee who have failed at least 1 conservative osteoarthritis (OA) therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

Full description

A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee who have failed at least 1 conservative OA therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

Enrollment

46 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Male or female ≥40 years and ≤75 years.
Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
Diagnosis of knee osteoarthritis (OA) Grade 2 or 3 according to the Kellgren-Lawrence scale
Body mass index (BMI) ≤ 40.
Failed at least 1 conservative OA therapy
Signed an independent ethics committee (IEC) approved informed consent form (ICF).

Main Exclusion Criteria:

Intra-articular Hyaluronic (HA) injection within 6 months- On Day 1 (pre-injection), presence of active infection or abnormal effusion in the knee as noted by a physical examination (e.g., erythema, redness, heat, swelling).
Presence of symptomatic OA in the non-study knee.
Diagnosed with rheumatoid arthritis (RA), Reiter's syndrome, psoriatic arthritis, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases (e.g., inflammatory bowel disease [IBD], sarcoidosis, or amyloidosis) or of metabolic origin.
Diagnosis of isolated patella-femoral joint osteoarthritis.
Valgus/varus deformity judged by the investigator to be clinically significant.
Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee. Patients with TKR at the contra-lateral knee or THR in either hip may be enrolled provided sufficient pain relief after TKR or THR which does not require additional analgesic relief.
Untreated acute traumatic injury of the index knee.
Presence of a symptomatic meniscal tear in the index knee
Limited daily activity for reasons other than OA.
Presence of surgical hardware or other foreign body in the index knee.