N/A N=11 Treatment

Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)

Gonarthrosis · Knee Osteoarthritis · Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT01773226 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Number of Adverse Events — 22 Adverse Events (AEs)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Autologous Protein Solution "APS(TM)" (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Zimmer Biomet
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Adverse Events	22	—
SECONDARY Number of Patients Using Rescue Medication	2; 2	—
SECONDARY Pain Score	12; 8.2; 6.5; 4.5; 3.0; 3.1	—
SECONDARY Stiffness Score	4.9; 3.8; 3.1; 2.5; 1.7; 2.3	—
SECONDARY Physical Function Score	38.1; 27.8; 21.9; 17.5; 10; 12.3	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01773226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.