Treatment Trials

12 Clinical Trials for Various Conditions

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COMPLETED
A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity
Description

This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo.

RECRUITING
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Description

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty

RECRUITING
Cemented vs Cementless Persona Keel RCT
Description

The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.

ACTIVE_NOT_RECRUITING
Persona Ti-Nidium Post-Market Clinical Follow-up
Description

The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.

TERMINATED
Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
Description

Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).

COMPLETED
Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy
Description

The primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. Placebo in the management of acute postoperative pain in patients undergoing bunionectomy. Secondary objective of this study is to evaluate the safety and tolerability of a single intraoperative administration of 4975.

Conditions
COMPLETED
ROSA Robot Used in Total Knee Replacement Post Market Study
Description

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.

ACTIVE_NOT_RECRUITING
Persona Total Knee Arthroplasty Outcomes Study
Description

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.

COMPLETED
Persona TM Tibia Clinical Outcomes Study
Description

The primary objective of this study is to evaluate clinical performance for the commercially available Persona TM Tibia used in primary cementless tibia total knee arthroplasty.

COMPLETED
NexGen TM Tibia Clinical Outcomes Study
Description

The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.

COMPLETED
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Description

The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.

TERMINATED
TMT Fusion Plate vs. Two Crossed Screws
Description

This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly assigned to one of these two treatment options.