Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02138890
Recruitment Status : Active, not recruiting
First Posted : May 15, 2014
Results First Posted : April 12, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: APS Device: Saline Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: APS injection
Autologous Protein Solution
Device: APS
Intra-articular Injection

Placebo Comparator: Control
Saline
Device: Saline
Intra-articular injection




Primary Outcome Measures :
  1. Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) [ Time Frame: 6 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).


  2. Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. [ Time Frame: 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).



Secondary Outcome Measures :
  1. Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months [ Time Frame: 12 Months ]
    The Visual Analogue Scale is a common tool for measuring general pain. A 100 mm line is marked from 0 to 10 in 10 mm increments. Knee pain severity is indicated by drawing a vertical mark at the point on the line that best represents the severity of pain. No pain is indicated by the 0 at the far left, and the worst possible pain is indicated by the 100 at the far right.

  2. Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months [ Time Frame: 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 Stiffness subscale consisted of two questions scored from 0 to 4. The Stiffness has a range of 0(no stiffness) to 8 (maximal stiffness)


  3. 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 [ Time Frame: 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 Physical Functioning subscale consisted of seventeen questions scored from 0 to 4. The Physical Functioning has a range of 0 (no functional limitation) to 68 (maximal functional limitation)


  4. 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 [ Time Frame: 12 months ]

    The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.

    A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.


  5. 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 [ Time Frame: 12 months ]

    The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.

    A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.


  6. 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 [ Time Frame: 12 months ]

    The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.

    A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.


  7. 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 [ Time Frame: 12 months ]

    The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.

    A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.


  8. 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 [ Time Frame: 12 months ]

    The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.

    A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.


  9. Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months [ Time Frame: 12 Months ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Eight subscales of the Short Form-36 questionnaire are used to derive Physical Component and Mental Component measures

  10. Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months [ Time Frame: 12 Months ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  11. Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months [ Time Frame: 12 Months ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  12. Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months [ Time Frame: 12 Months ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  13. General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months [ Time Frame: 12 Months ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  14. Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months [ Time Frame: 12 Months ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  15. Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months [ Time Frame: 12 Months ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  16. Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months [ Time Frame: 12 Months ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138890


Locations
Layout table for location information
Austria
Krems Hospital
Krems, Austria
Belgium
Monica Hospitals
Antwerp, Belgium
Italy
Rizzoli Orthopaedic Institute
Bologna, Italy
Norway
Oslo University
Oslo, Norway
Sponsors and Collaborators
Zimmer Biomet
Investigators
Layout table for investigator information
Principal Investigator: E. Kon, MD Bologna (Italy)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02138890     History of Changes
Other Study ID Numbers: BBI.CR.APS1.14
First Posted: May 15, 2014    Key Record Dates
Results First Posted: April 12, 2019
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zimmer Biomet:
Autologous Protein Solution
APS
Osteoarthritis
Intra Articular Injection

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pharmaceutical Solutions