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PROGRESS III: Prospective Post-Market Data Collection on Patients With Knee OA and Treated With nSTRIDE APS

Sponsor
Zimmer Biomet (Industry)
Overall Status
Completed
CT.gov ID
NCT02580643
Collaborator
(none)
78
Enrollment
1
Location
37.9
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will document treatment effects, changes in quality of life, procedure complications, adverse events, healthcare resource utilization, and further needed intervention(s) following treatment with nSTRIDE autologous protein solution. This study will also allow for the documentation of the same parameters following multiple injections of autologous protein solution to treat knee osteoarthritis.

Condition or Disease Intervention/Treatment Phase
  • Biological: APS

Detailed 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. It appears that the safety of autologous therapies is roughly equivalent across different processing methods. However, making generalizations regarding the effectiveness across these autologous therapies is more complicated. Thus, 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 small pilot trial. However, demonstration of the treatment effects in a more heterogeneous population is lacking. Further, neither the effect time course nor the utility of multiple injections has been documented. This study will allow for low burden, efficient data collection in a larger heterogeneous population of persons suffering from knee OA. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following single or repeated injections.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
78 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Prospective Post-Market Data Collection on Patients With Knee Osteoarthritis and Treated With nSTRIDE Autologous Protein Solution (REGP-22-00)
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Jun 30, 2019

Arms and Interventions

Arm Intervention/Treatment
APS Injection

Autologous Protein Solution

Biological: APS
intra-articular injection

Outcome Measures

Primary Outcome Measures

  1. Knee pain and function [Through 12 months]

    Quantify and characterize the percentage of OMERACT-OARSI high improvement in pain responders at all post-injection time points. OMERACT-OARSI high improvement in pain responders are defined as subjects who show a 50% improvement in the KOOS pain sub-scale score and an absolute improvement of at least 20 points on the KOOS pain subscale score.

Secondary Outcome Measures

  1. Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment. [Through 12 months]

  2. Numeric Rating Scales (NRS) [Evaluated at 2 and 4 weeks and 3, 6 and 12 months]

    Quantify the change in knee pain, stiffness and function

  3. European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L) [Evaluated at 2 and 4 weeks and 3, 6 and 12 months]

    Quantify the change in quality of life

  4. Knee Injury and Osteoarthritis Outcome Score (KOOS) [Evaluated at 2 and 4 weeks and 3, 6 and 12 months]

    Quantify changes in pain, symptoms, activities of daily life, engagement in sports and recreation and quality of living

  5. Procedural complications and adverse events [Through 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • OA of one or both knees as diagnosed by the treating physician

  • At least 18 years of age

  • Willing and able to comply with the study procedures

  • Signed informed consent form

Exclusion Criteria:

  • Any systemic inflammatory condition ( e.g., rheumatoid arthritis)

  • Active malignancy at time of injection

  • Pregnant at time of injection

  • Lactating at the 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

  • Participating in another device or drug study

Contacts and Locations

Locations

Site City State Country Postal Code
1 BMI Bishops Wood Hospital Northwood United Kingdom HA6 2JW

Sponsors and Collaborators

  • Zimmer Biomet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT02580643
Other Study ID Numbers:
  • BBIO.CRNSAPS002.15
First Posted:
Oct 20, 2015
Last Update Posted:
Jun 11, 2020
Last Verified:
Jun 1, 2020
Keywords provided by Zimmer Biomet
Autologous Protein Solution
Osteoarthritis
Intra-articular Injection
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee

Study Results

No Results Posted as of Jun 11, 2020