N/A N=46 Randomized Quadruple-blind Treatment

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

Osteoarthritis, Knee

Bottom Line

View on ClinicalTrials.gov: NCT02138890 ↗

Enrolled (actual)

Serious AEs

6.5%

Results posted

Apr 2019

Primary outcome: Primary: Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) — 11.5; 11.8; 8.6; 8.7 scores on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: APS (Device); Saline (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Zimmer Biomet
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6)	11.5; 11.8; 8.6; 8.7; 7.0; 8.4	—
PRIMARY Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months.	11.5; 11.8; 8.6; 8.7; 7.0; 8.4	—
SECONDARY Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months	5.5; 6.5; 4.7; 5.3; 4.0; 5.2	—
SECONDARY Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months	4.8; 5.0; 4.0; 3.6; 3.3; 3.9	—
SECONDARY 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	34.9; 38.1; 30.2; 29.4; 24.9; 28.9	—
SECONDARY 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	39.9; 37.9; 51.1; 48.0; 58.2; 51.8	—
SECONDARY 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	47.8; 46.4; 55.4; 54.9; 64.2; 56.1	—
SECONDARY 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	48.6; 44.0; 55.5; 56.8; 63.4; 57.5	—
SECONDARY 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	23.1; 14.3; 29.0; 23.2; 30.7; 26.6	—
SECONDARY 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	26.5; 22.3; 29.0; 23.2; 30.7; 26.8	—
SECONDARY Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months	35.8; 33.9; 43.3; 42.0; 43.5; 42.2	—
SECONDARY Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months	51.5; 50.8; 54.1; 53.8; 55.2; 53.0	—
SECONDARY Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months	38.5; 38.8; 44.1; 45.7; 46.0; 42.4	—
SECONDARY Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months	36.7; 35.0; 44.0; 43.7; 47.0; 39.2	—
SECONDARY General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months	36.7; 35.0; 44.0; 43.7; 47.0; 39.2	—
SECONDARY Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months	51.7; 50.6; 54.0; 52.4; 54.6; 53.1	—
SECONDARY Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months	43.7; 44.5; 49.6; 51.4; 51.5; 47.6	—
SECONDARY Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months	44.0; 39.5; 48.1; 47.5; 49.6; 42.5	—

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02138890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.