Gait Analysis in Patients Underwent Total Knee Arthroplasty With a Medial Pivot Design.

NCT04244838 | Completed

• 1 other identifier: MP-TKA-GAIT
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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

Knee Osteoarthritis

Keywords

Medially stabilized total knee arthroplasty; In vivo kinematics; gait analysis

Outcome Measures

Primary Outcomes (5)

• Gait analysis

  Spatio-temporal parameters, kinematics of pelvis, hip, knee and ankle in the sagittal coronal and transverse planes, kinetics (joint moments and foot-soil reaction forces), rectus femoral muscle activation, biceps femoris, anterior tibialis, medial twin during the path, ascent and descent from stairs, lunge, path on unstable surface

  20 months

• American Knee Society Score

  It is used to assess knee functionality by investigator. It consists of both a clinical and a functional score

  22 months

• Knee injury and Osteoarthritis Outcome Score

  KOOS is a valid, reliable and responsive self-administered instrument that can be used for short-term and long-term follow-up of several types of knee injury including osteoarthritis. It consists of five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QoL).

  22 months

• Visual analogue scale

  It is used for subjective pain evaluation

  22 months

• Short Form-36

  36 items presented in eight dimensions (physical activity, monitoring of the role due to physical health, emotional state, physical pain, perception of the general state of health, vitality, social activities and mental health).

  22 months

Study Arms (1)

MP-TKA group

EXPERIMENTAL

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.

Diagnostic Test: Gait Analysis

Interventions

Gait Analysis DIAGNOSTIC_TEST

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.

MP-TKA group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 50-75 years of both gender
• 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

You may not qualify if:

• Patients with severe morphostructural alterations or other pathologies affecting the knee and lower limb
• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (9)

• 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.

  PMID: 21437943 RESULT

• 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.

  PMID: 29292344 RESULT

• 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.

  PMID: 20570095 RESULT

• 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.

  PMID: 20728970 RESULT

• 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.

  PMID: 17291764 RESULT

• 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.

  PMID: 21887700 RESULT

• 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.

  PMID: 16169000 RESULT

• 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.

  PMID: 19333579 RESULT

• 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.

  PMID: 17557876 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Giulio Maria Marcheggiani Muccioli, MD, PhD

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 28, 2020
• Study Start: July 29, 2019
• Primary Completion: May 19, 2024
• Study Completion: May 19, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)