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

NCT02138890 | Completed Results

• 1 other identifier: BBI.CR.APS1.14
• Study Type: interventional
• Target: 46
• Locations: 4 countries
• Sites: 4

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).

Conditions

Osteoarthritis, Knee

Keywords

Autologous Protein Solution; APS; Osteoarthritis; Intra Articular Injection

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6)

  The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain).

  6 months

• Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months.

  The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain).

  12 Months

Secondary Outcomes (16)

• Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months

  12 Months

• Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months

  12 months

• 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

  12 months

• 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

  12 months

• 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

  12 months

Study Arms (2)

APS injection

EXPERIMENTAL

Autologous Protein Solution

Device: APS

Control

PLACEBO COMPARATOR

Saline

Device: Saline

Interventions

APS DEVICE

Intra-articular Injection

APS injection

Saline DEVICE

Intra-articular injection

Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Krems Hospital

Krems, Austria

Location

Monica Hospitals

Antwerp, Belgium

Location

Rizzoli Orthopaedic Institute

Bologna, Italy

Location

Oslo University

Oslo, Norway

Location

Related Publications (2)

• 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.

  PMID: 32870042 DERIVED

• 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.

  PMID: 29016185 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Mr. Cahit Akbas
• Organization: Zimmer Biomet

Cahit.Akbas@zimmerbiomet.com

+31622981737

Study Officials

• DiMartino, MD

  Bologna (Italy)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 15, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: September 15, 2020
• Last Updated: February 5, 2021
• Results First Posted: April 12, 2019

Record last verified: 2021-01

Locations

AU (1); NO (1); BE (1); IT (1)