Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02610192
Other study ID # BBIO.CR.APSPFO.001.15
Secondary ID APSS-55-00
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date June 2018

Study information

Verified date June 2020
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate clinical outcomes following a single injection of nSTRIDE Autologous Protein Solution in females with isolated patellofemoral osteoarthritis. A secondary objective of this study is to document the duration of treatment effect following nSTRIDE injection.


Description:

Clinical trials have, in general, formally demonstrated the effectiveness and safety of various autologous therapies for the treatment of knee OA. Differences in the processing of autologous therapies can yield substantial differences in the resulting output. Thus, making generalizations regarding the effectiveness across these autologous therapies is more complicated. Each autologous therapy requires independent efficacy evaluation. nSTRIDE APS has been shown to decrease pain, increase function and have a favorable safety profile in a pilot trial. Further, demonstration of the treatment effects in patellofemoral osteoarthritis, an important subset of knee osteoarthritis is lacking. This study will evaluate a population of female patients with patellofemoral osteoarthritis in which treatment with other modalities provides limited/short lived relief with the hope that APS treatment will provide and extend relief to these patients. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following a single injection (per symptomatic knee).


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria:

- Patient must be female

- Isolated patellofemoral osteoarthritis (PFOA) in one or both knees as diagnosed by the treating physician

- Objective evidence of PFOA on one or both of a radiograph or MRI taken within 3 months of treatment

- From 40-65 years of age, inclusive at time of injection

- Symptoms return such that there is a need for further treatment within 3 months of a corticosteroid or hyaluronic acid injection

- Willing and able to comply with the study procedures

- Sign informed consent form

Exclusion Criteria:

- Any systematic inflammatory condition (e.g. rheumatoid arthritis)

- Active malignancy at time of injection

- Pregnant at time of injection

- Lactating at time of injection

- Knee joint infections or skin diseases or infections in the area of the injection site

- Leukemia, metastatic malignant cells, or who are receiving chemotherapeutic treatment

- Participation in another device, biologic or drug study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
nSTRIDE Autologous Protein Solution (APS) Kit
Intra-articular injection of APS

Locations

Country Name City State
Belgium AZ Monica Deurne

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original 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). On this scale, 100% indicates no problems and 0% indicates extreme problems. Baseline, 1, 3, 6 and 12 Months
Secondary Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original 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). On this scale, 100% indicates no problems and 0% indicates extreme problems Baseline, 1, 3, 6 and 12 Months
Secondary Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original 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). On this scale, 100% indicates no problems and 0% indicates extreme problems Baseline, 1, 3, 6 and 12 Months
Secondary Function in Sport and Recreation (Sport/Rec) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Sport/Rec at 1, 3, 6 and 12 Months The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original 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). On this scale, 100% indicates no problems and 0% indicates extreme problems Baseline, 1, 3, 6 and 12 Months
Secondary Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original 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). On this scale, 100% indicates no problems and 0% indicates extreme problems Baseline, 1, 3, 6 and 12 Months
Secondary Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months The NRS is a validated measure of pain, stiffness and function. The NRS is an 11 point Likert type scale anchored by 0 "no pain" and 10 "worst possible pain". Subjects rate their average pain over the last 24 hours. Likewise subjects rate their stiffness and function on an 11 point Likert type scale Baseline, 1, 3, 6 and 12 Months
Secondary Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months The NRS is a validated measure of pain, stiffness and function. The NRS is an 11 point Likert type scale anchored by 0 "no pain" and 10 "worst possible pain". Subjects rate their average pain over the last 24 hours. Likewise subjects rate their stiffness and function on an 11 point Likert type scale Baseline, 1, 3, 6 and 12 Months
Secondary Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months The NRS is a validated measure of pain, stiffness and function. The NRS is an 11 point Likert type scale anchored by 0 "no pain" and 10 "worst possible pain". Subjects rate their average pain over the last 24 hours. Likewise subjects rate their stiffness and function on an 11 point Likert type scale Baseline, 1, 3, 6 and 12 Months
Secondary Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months The KAKPAQ is a 13-item screening instrument designed to assess patellofemoral pain and instability in adolescents and young adults, with a variable ordinal response format (3-5 choices). The questions included knee functional ability; limping, weight bearing, walking, stairs, squatting, running, jumping, prolonged sitting, pain swelling, painful patellar movement, muscle atrophy and flexion deficiency. Each answer had different scores. To calculate the total score, all items were summarized. The score '0' represented the greatest limitation of knee function, whereas the score '100' indicated the ability to perform most knee functions Baseline, 1, 3, 6 and 12 Months
Secondary Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months The UCLA Activity Score is a validated measure of subject activity. Subjects rate their current activity level from on a simple scale ranging from 1 to 10. The subject indicated her or his most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports Baseline, 1, 3, 6 and 12 Months
See also
  Status Clinical Trial Phase
Completed NCT06060730 - Measurement Properties of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS
Recruiting NCT04937998 - PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT N/A
Completed NCT02825238 - Effect of Hip and Core Muscle Strengthening for Patellofemoral Osteoarthritis: A Feasibility Study N/A
Completed NCT03281837 - 2 Weekly Intra-articular Hyaluronan Knee Injections, Given 1 wk. Apart, of HYMOVIS Combined With Physical Exercise Program (PEP) Compared to PEP Alone, in Relatively Young, Active Population of Subjects With Patellofemoral Osteoarthritis (PFOA) and/or Tibiofemoral Osteoarthritis (TFOA) N/A
Completed NCT05184439 - Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.
Not yet recruiting NCT04332900 - Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic in People With Patellofemoral Osteoarthritis N/A
Recruiting NCT06163573 - Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage. Phase 2
Completed NCT04589871 - Taping Technique With Supervised Exercises Protocol on Pain and Functional Status in Individuals With Arthritis N/A
Active, not recruiting NCT04817969 - Persona Ti-Nidium Post-Market Clinical Follow-up N/A
Active, not recruiting NCT04772625 - Failure Analysis of Patellofemoral Arthroplasty
Terminated NCT00816647 - A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction N/A