Clinical trials: Fixation
Bradycardia, Sinus Node Dysfunction
Safety and Performance Study of the INGEVITY Lead
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
- Trial name
- NCT01688843
- Testing
- INGEVITY lead
- Where
- 78 sites in United States, Australia and 14 more
- Volunteers
- 1,060 people
- Sponsor
- Boston Scientific Corporation
Femur Fractures
The CHINA TFNA Study
This is a prospective, multicenter, randomized, controlled, two-arm, non-inferiority study which will be conducted in China to support registration of a cephalomedullary nailing system (TFNA) that currently is available globally.
- Trial name
- TFNA (NCT03635320)
- Testing
- TFNA, PFNA-II
- Where
- 9 sites in China
- Volunteers
- 188 people
- Sponsor
- Synthes GmbH
Osteoarthritis
A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low LCS Porocoat Knee Systems
The primary objective of this investigation is to test the hypothesis that the Duofix Tibial component results in a reduction of immediate postoperative pain compared to the LCS Porocoat version.
- Trial name
- NCT00733499
- Testing
- LCS Complete Duofix, LCS Complete Porocoat
- Where
- Ireland
- Volunteers
- 206 people
- Sponsor
- DePuy International
Bunions, Postoperative Pain
Dose-Escalation Study of HTX-034 Following Bunionectomy
This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl.
- Trial name
- NCT04398329
- Testing
- HTX-034 low dose, HTX-034 high dose, Luer lock applicator
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Heron Therapeutics
Bradycardia
INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
- Trial name
- NCT04346537
- Testing
- INGEVITY+™ Pace/Sense Lead
- Where
- 13 sites in United States
- Volunteers
- 109 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Congestive
Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.
- Trial name
- NCT00112125
- Testing
- OPTIMIZER System
- Where
- United States
- Volunteers
- 428 people
- Sponsor
- Impulse Dynamics
Neuropathy, Charcot; Disease (Etiology)
Lower Extremity Fixation In Neuropathic Patients Study
Prospective, multi-site, multi-year post-market clinical follow-up study on neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di…
- Trial name
- FINS (NCT04607044)
- Testing
- SALVATION™ EXTERNAL FIXATION
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Stryker Trauma and Extremities
Fracture Healing
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).
- Trial name
- STARTT (NCT00907296)
- Testing
- Romosozumab
- Where
- 103 sites in United States, Australia and 21 more
- Volunteers
- 402 people
- Sponsor
- Amgen
Soft Tissue to Bone Fixation
PMCF Study on PEEK Suture Anchors for Hip Indications
Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.
- Trial name
- NCT03814044
- Testing
- PEEK Suture Anchors
- Where
- 4 sites in United States
- Volunteers
- 149 people
- Sponsor
- Smith & Nephew, Inc.
Fracture, Fractures, Bone
FastFrame Knee Spanning and Damage Control Kit PMCF
The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
- Conditions
- Fracture, Fractures, Bone, Fractures, Closed, Fractures, Open
- Trial name
- NCT04730739
- Testing
- FastFrame External Fixation System - Knee Spanning or Damage Control Kit
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Zimmer Biomet
Tibial Fractures
Study Evaluating InductOs in Diaphyseal Tibia Fractures
Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.
- Trial name
- NCT00161616
- Testing
- InductOs
- Where
- 27 sites in Belgium, Finland and 10 more
- Volunteers
- 277 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Periodontal Attachment Loss, Periodontal Diseases
Safety and Efficacy of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain
The primary objective of this study is to demonstrate that in supra-alveolar-type defects (i.e., defects displaying a predominately horizontal pattern of bone loss), periodontal surgery with the additional use of Straumann®…
- Trial name
- NCT01614925
- Testing
- Emdogain, Periodontal surgery
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Institut Straumann AG
Tibial Delayed Healing
Tibial Delayed Healing Pivotal Clinical Trial
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
- Trial name
- NCT01016067
- Testing
- INFUSE/MASTERGRAFT, Autograft bone
- Where
- 16 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation
The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease…
- Trial name
- NCT02068768
- Testing
- Avenue® L Interbody Fusion System (LDR Spine)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- LDR Spine USA
HIV Infections
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.
- Trial name
- NCT02362503
- Testing
- BMS-663068
- Where
- 139 sites in United States, Argentina and 23 more
- Volunteers
- 371 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF).
- Trial name
- NCT01384734
- Testing
- BMS-663068 400 mg, BMS-663068 800 mg, BMS-663068 600 mg
- Where
- 54 sites in United States, Argentina and 8 more
- Volunteers
- 254 people
- Sponsor
- ViiV Healthcare
HIV Infections
Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068, an HIV Attachment Inhibitor, in HIV-1
Research Hypothesis: Administration of BMS-663068, a prodrug for HIV attachment inhibitor BMS-626529, will result in a mean decrease of at least 1 log10 in HIV RNA at Day 9 following 8 days of therapy in at least one dosing…
- Trial name
- NCT01009814
- Testing
- BMS-663068, Ritonavir
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- ViiV Healthcare
Fracture Healing
Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.
- Trial name
- STARTT-Hip (NCT01081678)
- Testing
- Romosozumab
- Where
- 99 sites in United States, Argentina and 22 more
- Volunteers
- 332 people
- Sponsor
- Amgen
Wrinkle, Rosacea
Evaluation of Cutera Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment
Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array (MLA) Attachment
- Conditions
- Wrinkle, Rosacea, Scarring
- Trial name
- NCT03424304
- Testing
- Excel V™ Laser With Green Genesis
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cutera Inc.
Wounds and Injuries
Clinical Investigation of Two Different Wound Dressings
The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings The secondary objectives are to evaluate pain before, during, and after…
- Trial name
- NCT02904200
- Testing
- Silicon adhesive dressing, Acrylic adhesive dressing
- Where
- 2 sites in Sweden
- Volunteers
- 2 people
- Sponsor
- Molnlycke Health Care AB