NCT01773226

Brief Summary

This prospective single-center study will evaluate the safety and tolerability of a single dose of "APS(TM)" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assessing patient pain and functionality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 15, 2016

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

January 7, 2013

Results QC Date

March 22, 2016

Last Update Submit

January 8, 2018

Conditions

GonarthrosisKnee OsteoarthritisOsteoarthritis

Keywords

Autologous Protein SolutionAPSOsteoarthritisInjection

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months.

    Up to 6 months post-injection

Secondary Outcomes (4)

  • Number of Patients Using Rescue Medication

    Up to 6 months post-injection

  • Pain Score

    Baseline, Week 1, Week 2, and at Months 1, 3, and 6.

  • Stiffness Score

    Baseline, Week 1, Week 2, and at Months 1, 3, and 6.

  • Physical Function Score

    Baseline, Week 1, Week 2, and at Months 1, 3, and 6.

Study Arms (1)

Autologous Protein Solution "APS(TM)"

EXPERIMENTAL

Patients who have been treated with a single, intra-articular injection.

Device: Autologous Protein Solution "APS(TM)"

Interventions

Autologous Protein Solution "APS(TM)"DEVICE

A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins

Autologous Protein Solution "APS(TM)"

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Eligibility Criteria: * Male or female ≥40 years. * Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions. * A standing radiograph of the knee showing a Kellgren grade of 2 or 3 * Frequency of knee pain on most days over the last month. * Diagnosis of unilateral knee OA * Body mass index (BMI) ≤40 kg/m2. * Failed conservative OA therapy. * Signed an independent ethics committee (IEC)-approved informed consent form (ICF). * Willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study. * Willingness to abstain from systemic pain medications except rescue medication.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

St. Anna Hospital

Geldrop, Netherlands

Location

Related Publications (1)

  • King W, van der Weegen W, Van Drumpt R, Soons H, Toler K, Woodell-May J. White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution. J Exp Orthop. 2016 Dec;3(1):9. doi: 10.1186/s40634-016-0043-7. Epub 2016 Feb 9.

    PMID: 26915009DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

1. Small sample size 2. Unblinded observational study

Results Point of Contact

Title
Linda Korthout, Scientific Affairs Specialist
Organization
Zimmer Biomet
Linda.Korthout.external@zimmerbiomet.com
+31.610.072.853

Study Officials

  • R.A.M. van Drumpt, M.D.

    St. Anna Hospital, Geldrop, NL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 23, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 5, 2018

Results First Posted

June 15, 2016

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)