Gait Analysis in Patients Underwent Total Knee Arthroplasty With a Medial Pivot Design.
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 25 people enrolled
- Started
- 29 Jul 2019
- Ended
- 19 May 2024
- Type of study
- Interventional
- Treatments tested
- Gait Analysis
- Record updated
- 23 September 2024
Who can take part
- Age
- 50 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- MP-TKA groupTreatment being tested
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.
Treatment: Gait Analysis
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Biomechanical Functional Evaluation Through Gait Analysis in Patients Underwent Total Knee Arthroplasty With a Medial Pivot Design: Pilot Study
- Record updated
- 23 September 2024