Clinical trials: Instrumentation
Depression
Measuring Quality of Decisions About Treatment of Depression
The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of depression.
- Trial name
- NCT01152307
- Testing
- DVD/Booklet: Coping with Symptoms of Depression
- Where
- United States
- Volunteers
- 405 people
- Sponsor
- University of Massachusetts, Boston
Pulmonary Arterial Hypertension
A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain
Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study. Primary objectives: To evaluate the psychometric characteristics of reliability and construct validity of the French, Italian and Spanish…
- Trial name
- ORCHESTRA (NCT02081690)
- Testing
- Macitentan
- Where
- 39 sites in France, Italy and 1 more
- Volunteers
- 160 people
- Sponsor
- Actelion
Anatomic Total Shoulder Arthroplasty
Comparison of Glenoid Position Using SmartBones
The investigators propose a randomized clinical trial to evaluate the accuracy of glenoid implant placement comparing four groups of patients.
- Trial name
- NCT03035318
- Testing
- DePuy Global® Anchor Peg Glenoid Instrumentation, DePuy Global® Anchor Peg Instrumentation with SmartBone™, IRI with SmartBone™
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- The Cleveland Clinic
Trachoma
Modified Instrumentation for Surgery to Correct Trichiasis
Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C.
- Trial name
- NCT00886015
- Testing
- TT Clamp, Standard BLTR Technique
- Where
- United States
- Volunteers
- 1,927 people
- Sponsor
- Johns Hopkins University
Knee Arthritis
Knee Arthroplasty Performed With Conventional and Customized Instrumentation
The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional…
- Trial name
- CPI (NCT01124305)
- Testing
- Customized Patient Instrumentation, Traditional Instrumentation
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Anderson Orthopaedic Research Institute
Proximal Humeral Fracture, Proximal Tibia Fractures
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
The study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Zimmer® Plates…
- Conditions
- Proximal Humeral Fracture, Proximal Tibia Fractures, Diaphyseal Fracture
- Trial name
- NCT05215613
- Where
- Italy
- Volunteers
- 57 people
- Sponsor
- Zimmer Biomet
Disorder of Consciousness, Traumatic Brain Injury
Validity and Feasibility of the CRSR-FAST
The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings.
- Trial name
- CRSR-FAST (NCT03549572)
- Testing
- Coma Recovery Scale-Revised
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Massachusetts General Hospital
Down Syndrome, Health, Subjective
Developing a Down Syndrome Health Instrument
Although over 200,000 individuals with DS live in the United States, studies to date have focused on outcomes apart from health.
- Trial name
- NCT04631237
- Testing
- Observational, no intervention
- Where
- United States
- Volunteers
- 758 people
- Sponsor
- Massachusetts General Hospital
Knee Arthritis
Preoperative Alignment of Total Knee Replacement
The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.
- Trial name
- NCT01242085
- Testing
- trumatch group, control group
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- VA Palo Alto Health Care System
Pain
Endometrial Biopsy Instrument Comparison Study
The purpose of this study is to determine the level of pain women experience during an endometrial biopsy and the effect that the biopsy tool might have on that pain.
- Trial name
- NCT00613925
- Testing
- Pipelle de Cornier, Explora curette
- Where
- 2 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Pathology
Instrument Precision Study for Validation of Philips Dx
The objective of this study is to evaluate precision of the Philips Dx system.
- Trial name
- NCT02699970
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Osteoarthritis, Knee
Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation
This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement.
- Trial name
- NCT01108237
- Testing
- TruMatch™ Personalized Solutions, Total Knee Arthroplasty with Conventional Instrumentation.
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- DePuy Orthopaedics
Total Hip Arthroplasty
Real-Time Instrument for Acetabular Shell Positioning
The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty.
- Trial name
- RTI (NCT02006251)
- Testing
- Real-time Instrumentation, Standard Total Hip Arthroplasty
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- The Cleveland Clinic
Osteoarthritis, Post-traumatic Arthritis
ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty
This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable…
- Trial name
- SOLO (NCT02574312)
- Testing
- ATTUNE TKA with ATTUNE RUI, ATTUNE TKA with ATTUNE SUI
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 88 people
- Sponsor
- DePuy Orthopaedics
Osteo Arthritis Knee, Osteoarthritis
Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty
The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual…
- Trial name
- NCT04730271
- Testing
- Total Knee Replacement
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- DePuy Orthopaedics
Male Circumcision
Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.
- Trial name
- Unicirc003 (NCT02091726)
- Testing
- Unicirc instrument plus cyanoacrylate tissue adhesive
- Where
- South Africa
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Simunye Primary Health Care
Spinal Diseases
Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries).
- Trial name
- NCT03015142
- Testing
- New image-guidance software
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Degenerative Arthritis of Knee
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched…
- Trial name
- NCT01084772
- Testing
- VISIONAIRE Total Knee Arthroplasty, Standard Total Knee Arthroplasty
- Where
- 7 sites in United States, Australia
- Volunteers
- 134 people
- Sponsor
- Smith & Nephew, Inc.
Pulmonary Arterial Hypertension
Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension.
- Trial name
- NCT01841762
- Testing
- Macitentan
- Where
- 81 sites in United States
- Volunteers
- 284 people
- Sponsor
- Actelion
Degenerative Disc Disease, Spondylolisthesis
The European Robotic Spinal Instrumentation (EUROSPIN) Study
In a multinational prospective study, preoperative, intraoperative, perioperative and follow-up data on patients receiving thoracolumbar pedicle screw placement for degenerative disease or infections or tumors will be collected.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Recurrent Disc Herniation
- Trial name
- EUROSPIN (NCT03398915)
- Testing
- Transpedicular Instrumentation
- Where
- 12 sites in Austria, France and 5 more
- Volunteers
- 932 people
- Sponsor
- Marc Schröder