Oxford Partial Knee Comparative Instrument Pilot Study

Status Completed

Clinical Trial Summary

Clinical Trial Description

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and Conventional Instrumentation.

The FDA has approved the Oxford Partial Knee via Premarket Approval P010014. Also, by being CE marked, the Oxford Partial Knee also conforms to the essential requirements of EC Directive 93/42/EEC; in accordance to 13485:2003. The data gathered will be collated and used to provide feedback to design engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.

Surgical techniques and patient care are to be standard for the surgeon participating in the protocol for both treatment groups and should be maintained the same throughout the course of the data-collection. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling. Any use of the device or collection of clinical data outside of the United States should comply with all local, state, and/or national and international regulations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01410786
Study type	Interventional
Source	Zimmer Biomet
Contact
Status	Completed
Phase	N/A
Start date	June 2013
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03895489` - Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses	N/A
Completed	`NCT03660943` - A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain	Phase 3
Completed	`NCT04531969` - Comparison of Outpatient and Inpatient Spa Therapy	N/A
Completed	`NCT02848027` - Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment	Phase 3
Completed	`NCT05160246` - The Instant Effect of Kinesiology Taping in Patients With Knee OA	N/A
Recruiting	`NCT06080763` - Biomechanics and Clinical Outcomes in Responders and Non-Responders
Completed	`NCT03643588` - The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain	N/A
Active, not recruiting	`NCT05100225` - Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis	Phase 2
Active, not recruiting	`NCT04061733` - New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis	N/A
Completed	`NCT04051489` - A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
Recruiting	`NCT05546541` - Epidemiology and Nutrition
Recruiting	`NCT05447767` - Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg	Phase 2
Not yet recruiting	`NCT04448106` - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis	Phase 2
Not yet recruiting	`NCT03225911` - Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis	N/A
Completed	`NCT05070871` - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women	N/A
Completed	`NCT05703087` - Positive Cueing in Knee Arthroplasty.	N/A
Not yet recruiting	`NCT06042426` - Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population	Phase 4
Not yet recruiting	`NCT02826850` - Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial	Phase 3
Completed	`NCT02881775` - Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis	N/A
Terminated	`NCT02909257` - Motor-Sparing Femoral Nerve Block Dose	Phase 4