Arthritis, Rheumatoid Clinical Trial
Official title:
Open Label, Randomized, Blinded Study to Evaluate the Efficacy of Aquamantys System for Reducing the Transfusion Requirements Associated With the Anterior-Supine Intermuscular (ASI) Approach for Total Hip Arthroplasty (THA)
The purpose of this study is to establish whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.
To establish in a randomized, blinded study whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing based on early collected data. Data will be analyzed using StatsDirect in standard fashion to elucidate any difference between control and treatment groups. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01682512 -
Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
|
Phase 3 | |
| Completed |
NCT00539760 -
A Phase I Rheumatoid Arthritis Study in Healthy Volunteers
|
Phase 1 | |
| Active, not recruiting |
NCT03312465 -
Anatomical Shoulder Domelock System Study
|
||
| Completed |
NCT01208181 -
A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
|
Phase 3 | |
| Completed |
NCT03254810 -
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT01711814 -
A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
|
Phase 2 | |
| Completed |
NCT03315494 -
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers
|
Phase 1 | |
| Withdrawn |
NCT03241446 -
Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)
|
Phase 1 | |
| Completed |
NCT02748785 -
MTX Discontinuation and Vaccine Response
|
Phase 4 | |
| Completed |
NCT02553018 -
Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe
|
Phase 3 | |
| Active, not recruiting |
NCT02260778 -
Treat-to-target in RA: Collaboration To Improve adOption and adhereNce
|
N/A | |
| Completed |
NCT02569736 -
Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation
|
||
| Completed |
NCT01750931 -
This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.
|
Phase 2 | |
| Withdrawn |
NCT01204138 -
Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA
|
Phase 2 | |
| Not yet recruiting |
NCT01154647 -
Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes
|
N/A | |
| Completed |
NCT00973479 -
An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
|
Phase 3 | |
| Completed |
NCT00975130 -
Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
|
Phase 3 | |
| Completed |
NCT00913458 -
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
|
Phase 4 | |
| Completed |
NCT00550446 -
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
|
Phase 2 | |
| Completed |
NCT00660647 -
Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)
|
Phase 3 |