Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of

Status Completed

Clinical Trial Summary

The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and downhill walking by means of videofluoroscopy.

Clinical Trial Description

Total arthroplasty of the knee (TKA) aims to relieve patient pain and improve functionality of the joint. To maintain sufficient range of motion, but also not overload the surrounding soft tissue structures, reproduction of tibio-femoral kinematics of the healthy knee is thought to be beneficial. In previous studies, it has been shown that the medial condyle, described by the centre of the medial condylar sphere, does not move anterioposteriorly during progressing joint flexion, whereas the lateral condyle has been observed to translate in a posterior direction producing tibial internal rotation with flexion (Freeman and Pinskerova 2003, Pinskerova, Johal et al. 2004, Freeman and Pinskerova 2005). The GMK Sphere prosthesis is specifically designed to mimic the healthy kinematics with providing a medial pivot.

The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA as well as to the GMK UC Fixed Bearing. The study includes the simultaneous assessment of the 3D kinematics of the TKA by means of an automated moving fluoroscope and subsequent 2D/3D registration based on CAD models of the TKA, whole leg kinematics by means of skin markers and ground reaction forces during level walking, stair descent and downhill walking a 10° inclined slope. Precisely, the aim is to assess tibio-femoral kinematics in 8-10 TKA subjects implanted one or more years previously with the GMK Sphere prosthesis. In addition, 8-10 conventional GMK PS Fixed Bearing TKA subjects, as well as 8-10 GMK UC Mobile Bearing TKA subjects will be measured to provide a comparison against the GMK Sphere prosthesis kinematics. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03041857
Study type	Observational
Source	Institute for Biomechanics, ETH Zürich
Contact
Status	Completed
Phase	N/A
Start date	December 2013
Completion date	September 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03542981` - Interferential Current Therapy After Total Knee Arthroplasty	N/A
Recruiting	`NCT04458480` - Effect of Fast Inpatient Rehabilitation After TKA
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Recruiting	`NCT06061367` - Muscles Strength and Gait Parameteres After TKA
Recruiting	`NCT05391828` - Persona MC vs PS RCT With ROSA	N/A
Active, not recruiting	`NCT04850300` - Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses	Phase 3
Completed	`NCT05635916` - Trial of Liposomal Bupivacaine for TKA	Phase 4
Enrolling by invitation	`NCT05130216` - Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Withdrawn	`NCT02495805` - Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty	N/A
Completed	`NCT03206554` - Local Infiltration Analgesia in Total Knee Arthroplasty	Phase 2
Withdrawn	`NCT01511211` - Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic	Phase 4
Completed	`NCT01616836` - Optimizing Pain and Rehabilitation After Knee Arthroplasty	Phase 3
Not yet recruiting	`NCT00958945` - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements	N/A
Completed	`NCT00985920` - Topical Tranexamic Acid for Total Knee Arthroplasty	Phase 4
Completed	`NCT00761956` - A Study to Compare the NexGen CR and CR-Flex Knee Implants	N/A
Completed	`NCT03289247` - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty	N/A
Terminated	`NCT03316118` - US Guided GNB vs Saline Injection for TKA	Phase 4
Recruiting	`NCT05962970` - Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty	N/A
Completed	`NCT03317834` - Navio With Total Knee Arthroplasty
Enrolling by invitation	`NCT06188091` - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms