N/A
Completed N=11
Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)
Gonarthrosis · Knee Osteoarthritis · Osteoarthritis
Source: ClinicalTrials.gov NCT01773226 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Number of Adverse Events — 22 Adverse Events (AEs)
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.
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 | — |
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.
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. Informational only — not medical advice.