Clinical trial NCT02138890: APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA)
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Pilot Study of a Single, Intra-Articular Injection of Autologous Protein Solution (APS) in Patients With Osteoarthritis (OA) of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Autologous Protein Solution
APS
Osteoarthritis
Intra Articular Injection
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-05-15
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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).

Eligibility 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.

Primary outcomes:
measure: Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6)
timeFrame: 6 months
measure: Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months.
timeFrame: 12 Months
Secondary outcomes:
measure: Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
timeFrame: 12 Months
measure: Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
timeFrame: 12 months
measure: Function on Daily Living Measured With WOMAC Subscale Questionnaire Physical Functioning at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
timeFrame: 12 months
measure: Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
timeFrame: 12 months
measure: Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Symptoms at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
timeFrame: 12 months
measure: Function in Daily Living Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Function in Daily Living at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
timeFrame: 12 months
measure: Sports and Recreational (Sport/Rec) Activities Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Sport/Rec at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
timeFrame: 12 months
measure: Quality of Life Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Quality of Life Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
timeFrame: 12 months
measure: Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months
timeFrame: 12 Months
measure: Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months
timeFrame: 12 Months
measure: Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months
timeFrame: 12 Months
measure: Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months
timeFrame: 12 Months
measure: General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months
timeFrame: 12 Months
measure: Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months
timeFrame: 12 Months
measure: Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months
timeFrame: 12 Months
measure: Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Krems
country: Austria
facility: Krems Hospital
city: Antwerp
country: Belgium
facility: Monica Hospitals
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
city: Oslo
country: Norway
facility: Oslo University
Study officials:
affiliation: Bologna (Italy)
name: DiMartino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kon E, Engebretsen L, Verdonk P, Nehrer S, Filardo G. Autologous Protein Solution Injections for the Treatment of Knee Osteoarthritis: 3-Year Results. Am J Sports Med. 2020 Sep;48(11):2703-2710. doi: 10.1177/0363546520944891.
citation: Kon E, Engebretsen L, Verdonk P, Nehrer S, Filardo G. Clinical Outcomes of Knee Osteoarthritis Treated With an Autologous Protein Solution Injection: A 1-Year Pilot Double-Blinded Randomized Controlled Trial. Am J Sports Med. 2018 Jan;46(1):171-180. doi: 10.1177/0363546517732734. Epub 2017 Oct 10.