Gait Analysis in Patients Underwent Total Knee Arthroplasty With a Medial Pivot Design.
NCT ID: NCT04244838
Last Updated: 2024-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
25 participants
INTERVENTIONAL
2019-07-29
2024-05-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
On the day of admission to the ward (generally the day before the scheduled surgery), the enrolled patients will undergo the evaluation scales and gait analysis at the Institute's Movement Analysis Laboratory.
The patients will be operated by the team of the Traumatological Orthopedic Clinic 2nd through the implantation of a cemented total knee prosthesis MP (Evolution medial-pivot knee system, MicroPort Orthopedics). Anterior knee access with medial para-patellar capsulotomy and standard instruments will be used according to current standards of good clinical practice.
In the post-operative period, patients will carry out post-surgical rehabilitation following normal clinical practice.
The patients will be re-evaluated at a 6-month follow-up through gait analysis and evaluation scales on the occasion of the control visit that takes place, according to the normal clinical practice at the Institute.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics
NCT03448198
The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty
NCT04803578
Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic Alignment
NCT04912973
Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment
NCT04226339
Gait Analysis and Gait Training in Patient With Total Hip or Total Knee Replacement
NCT03849638
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Medial Pivot (MP) knee prostheses have been designed to meet these requirements by replicating the morphology of the healthy knee, characterized by a medial compartment with a stable conformation and a movable lateral compartment that moves by rotating around the pivot point. Despite the theoretical premises of this prosthetic model, in literature very few studies have investigated how the MP design translates into an improvement of the functional outcome of the subject operated during the journey, while no study has ever been conducted to evaluate the functional outcome during the execution of more demanding motor tasks although the subjects who undergo knee arthroplasty are always younger and more and more active, with increasingly higher functional needs. To date, gait analysis, a non-invasive functional assessment method that provides objective and quantitative data about spatio-temporal parameters, kinematics, kinetics and muscle activation, represents the Gold Standard for the assessment of functional outcome both in healthy patients and in patients subjected to prosthetic surgery.
The purpose of the present pilot study is to evaluate, through gait analysis and rating scales, the functional outcome during the execution of motor tasks with high functional demand such as walking on an unstable surface, stair ascent and descent, maximal knee flexion under load (lunge) on a sample of 20 subjects candidates to cemented total knee arthroplasty with MP design at the Orthopedic and Traumatology Clinic 2nd of the Rizzoli Orthopedic Institute. The parameters obtained will be compared with the parameters of healthy subjects comparable by age and Body Max Index (BMI) already acquired at the Movement Analysis Laboratory of the Rizzoli Orthopedic Institute, where the study will be conducted.
The pilot study is necessary to carry out a preliminary assessment of the functional outcome and joint biomechanics of the knee prosthesis with the gait analysis method never performed in other studies during the execution of demanding motor tasks, with high functional demand. The collection of information and data obtained will allow the appropriate calculation of the sample useful for a subsequent study.
During the pre-hospitalization visit, participation in the study will be proposed to those who meet the inclusion criteria. If the subject accepts, he will be recruited and will have to sign the informed consent to the study.
On the day of admission to the ward (generally the day before the scheduled surgery), the enrolled patients will undergo the evaluation scales and gait analysis at the Institute's Movement Analysis Laboratory.
The patients will be operated by the team of the Traumatological Orthopedic Clinic 2nd through the implantation of a cemented total knee prosthesis MP (Evolution medial-pivot knee system, MicroPort Orthopedics). Anterior knee access with medial para-patellar capsulotomy and standard instruments will be used according to current standards of good clinical practice.
In the post-operative period, patients will carry out post-surgical rehabilitation following normal clinical practice.
The patients will be re-evaluated at a 6-month follow-up through gait analysis and evaluation scales on the occasion of the control visit that takes place, according to the normal clinical practice at the Institute.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MP-TKA group
20 patients candidates for cemented TKA with MP design for tri-compartment gonarthrosis will be recruited on indications of the surgeon and according to normal clinical practice at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute.
Gait Analysis
The patients will undergo Gait analysis (integrated movement analysis system) performed at the Complex Laboratory for Movement Analysis and functional-clinical evaluation of the prosthesis of the Rizzoli Orthopedic Institute. The instrumentation used in the Movement Analysis Laboratory consists of a stereophotogrammetric system equipped with eight infrared cameras (Vicon® 460-Oxford system) and 2 dynamometric platforms (Kistler® Instrument, AG Switzerland). The IOR GAIT protocol will be used as a marker set (Leardini et al. 2007). For the evaluation of muscle activation, surface electromyography with 16-channel system will be used (ZeroWire Cometa, Milan). Spatio-temporal parameters, kinematics, kinetics and muscle activation will be evaluated.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gait Analysis
The patients will undergo Gait analysis (integrated movement analysis system) performed at the Complex Laboratory for Movement Analysis and functional-clinical evaluation of the prosthesis of the Rizzoli Orthopedic Institute. The instrumentation used in the Movement Analysis Laboratory consists of a stereophotogrammetric system equipped with eight infrared cameras (Vicon® 460-Oxford system) and 2 dynamometric platforms (Kistler® Instrument, AG Switzerland). The IOR GAIT protocol will be used as a marker set (Leardini et al. 2007). For the evaluation of muscle activation, surface electromyography with 16-channel system will be used (ZeroWire Cometa, Milan). Spatio-temporal parameters, kinematics, kinetics and muscle activation will be evaluated.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with three-compartment knee arthrosis (primary or secondary post-traumatic)
* Patients with femoral or tibial osteonecrosis
* Patients with posterior cruciate ligament and healthy collateral ligaments at the level of the affected knee
* Deformity in varus or valgus inferior to 10 °
* Person able to provide informed consent and who agrees to sign the Informed Consent Form approved by the Ethics Committee (EC).
* Subject compliant with post-operative rehabilitation to be performed according to normal clinical practice
Exclusion Criteria
* Patients with serious systemic vascular and neurological pathologies
* Obese or body mass index BMI\> 30 kg / m2
* Patients with posterior cruciate ligament and / or collateral ligaments injury in the affected knee
* Knee arthroplasty in the contralateral
* Patient not compliant with post-operative rehabilitation
50 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istituto Ortopedico Rizzoli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giulio Maria Marcheggiani Muccioli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Istituto Ortopedico Rizzoli
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Alnahdi AH, Zeni JA, Snyder-Mackler L. Gait after unilateral total knee arthroplasty: frontal plane analysis. J Orthop Res. 2011 May;29(5):647-52. doi: 10.1002/jor.21323. Epub 2010 Dec 23.
Benjamin B, Pietrzak JRT, Tahmassebi J, Haddad FS. A functional comparison of medial pivot and condylar knee designs based on patient outcomes and parameters of gait. Bone Joint J. 2018 Jan;100-B(1 Supple A):76-82. doi: 10.1302/0301-620X.100B1.BJJ-2017-0605.R1.
Hatfield GL, Hubley-Kozey CL, Astephen Wilson JL, Dunbar MJ. The effect of total knee arthroplasty on knee joint kinematics and kinetics during gait. J Arthroplasty. 2011 Feb;26(2):309-18. doi: 10.1016/j.arth.2010.03.021. Epub 2010 May 31.
Hubley-Kozey CL, Hatfield GL, Astephen Wilson JL, Dunbar MJ. Alterations in neuromuscular patterns between pre and one-year post-total knee arthroplasty. Clin Biomech (Bristol). 2010 Dec;25(10):995-1002. doi: 10.1016/j.clinbiomech.2010.07.008. Epub 2010 Aug 21.
Leardini A, Sawacha Z, Paolini G, Ingrosso S, Nativo R, Benedetti MG. A new anatomically based protocol for gait analysis in children. Gait Posture. 2007 Oct;26(4):560-71. doi: 10.1016/j.gaitpost.2006.12.018. Epub 2007 Feb 8.
Levinger P, Menz HB, Morrow AD, Perrott MA, Bartlett JR, Feller JA, Bergman NB. Knee biomechanics early after knee replacement surgery predict abnormal gait patterns 12 months postoperatively. J Orthop Res. 2012 Mar;30(3):371-6. doi: 10.1002/jor.21545. Epub 2011 Sep 1.
McIntosh AS, Beatty KT, Dwan LN, Vickers DR. Gait dynamics on an inclined walkway. J Biomech. 2006;39(13):2491-502. doi: 10.1016/j.jbiomech.2005.07.025. Epub 2005 Sep 15.
Moonot P, Mu S, Railton GT, Field RE, Banks SA. Tibiofemoral kinematic analysis of knee flexion for a medial pivot knee. Knee Surg Sports Traumatol Arthrosc. 2009 Aug;17(8):927-34. doi: 10.1007/s00167-009-0777-1. Epub 2009 Mar 31.
Naal FD, Fischer M, Preuss A, Goldhahn J, von Knoch F, Preiss S, Munzinger U, Drobny T. Return to sports and recreational activity after unicompartmental knee arthroplasty. Am J Sports Med. 2007 Oct;35(10):1688-95. doi: 10.1177/0363546507303562. Epub 2007 Jun 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MP-TKA-GAIT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.