Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses

NCT04850300 | Active Not Recruiting Phase 3

• 1 other identifier: 2020/181
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

Total knee arthroplasty (TKA) is currently the international standard for the treatment of degenerative and rheumatological diseases of the knee joint, as well as certain types of fractures. Although TKA is a procedure that has been shown to be effective in relieving pain and improving function in patients with osteoarthritis, approximately 20% of patients are dissatisfied with the results. Traditional methods of assessing the outcome after joint arthroplasty often focus on objective indicators of surgery and neglect the needs and opinions of patients. Because of this, this research project has the aim to know the effectiveness of two models of stabilization of total knee prostheses on the functionality achieved and perceived by the patient, as well as in the knee joint biomechanics during movement in activities of daily life. On the other hand, as a secondary objective, we propose to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers, and biomechanical functional evaluation that correlate and predict a correct evolution of patients with a knee replacement. To carry out these objectives, 80 participants will be included with an indication to perform total knee joint replacement surgery. Participants will be randomized allocated into two groups: i. participants with a prosthesis with medial condylar stabilization ii. participants with a traditional prosthesis with central pivot stabilization. Participants will be evaluated at five-times: before surgery, immediate postsurgical, at 3 months of evolution, 6 months of evolution, and one year of evolution.

Conditions

Total Knee Arthroplasty

Keywords

Total knee arthroplasty; Functional assessment; Prognosis biomarkers; Medial condylar stabilization; Central pivot stabilization

Outcome Measures

Primary Outcomes (1)

• Maximum walking speed (MWS)

  Maximum distance traveled by the body per unit of time (m·s-1). It will ask for participants to walk safely and as quickly as possible, without running, in a 10 m, straight and flat walkway. The two first and last stride will be discarded from the analysis in order to avoid the acceleration and deceleration of the star and end of the gait. The gait speed will be measured with the NedAMH/IBV v5.6 (Institute of Biomechanics of Valencia, Spain) software which uses two infrared or red light photocells to measured gait speed. This outcome will be measured in all the assessment times of the study.

  1 year

Secondary Outcomes (46)

• Self-reported pain

  1 year

• Self-reported knee function - Knee Osteoarthritis Outcome Score

  1 year

• Self-reported knee function - Western Ontario and McMaster Universities Osteoarthritis Index

  1 year

• Self-reported Physical activity

  1 year

• Joint awareness

  1 year

Study Arms (2)

Total knee prosthesis 1

EXPERIMENTAL

prosthesis with medial condylar stabilization

Procedure: Total knee prosthesis with medial condylar stabilization

Total knee prosthesis 2

ACTIVE COMPARATOR

traditional prosthesis with central pivot stabilization

Procedure: Total knee prosthesis with central pivot stabilization

Interventions

Total knee prosthesis with medial condylar stabilization PROCEDURE

Surgery will be done of Total knee prosthesis with medial condylar stabilization

Total knee prosthesis 1

Total knee prosthesis with central pivot stabilization PROCEDURE

Surgery will be done of Total knee prosthesis with central pivot stabilization

Total knee prosthesis 2

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People between 50-85 years old and,
• Primary total knee prosthesis surgery indication with patellar fitting.

You may not qualify if:

• Previous lower limb joint prosthesis,
• History of fracture or surgery in the lower limb or lumbar spine,
• Disabling contralateral knee pain,
• Lower limb length asymmetry \> 2 cm,
• Walking impairment due to other causes non-related to the knee pathology,
• Body Max Index \> 39, and
• Severe surgical complications such as infection, aseptic loosening, deep vein thrombosis, periprosthetic fracture, and arthrofibrosis.

Sponsors & Collaborators

• University of Valencia: lead
• Instituto de Investigacion Sanitaria INCLIVA: collaborator

Study Sites (2)

Orthopedic Surgery and Traumatology Service of the University Clinical Hospital of Valencia

Valencia, 46010, Spain

Location

Unidad de Evaluación en Autonomía Personal, Dependencia y Trastornos Mentales Graves (TMAP), University of Valencia

Valencia, 46010, Spain

Location

Related Publications (10)

• Poley González A, Ortega Blanco JA, Pedregal González M, Martín Azofra M, Hermosilla Camacho C, Mora Moreno F. Prevalencia de enfermedades osteoarticulares y consumo de recursos. Calidad de vida y dependencia en pacientes con artrosis. Med Fam SEMERGEN. 2011;37(9):462-7.

  BACKGROUND

• Rodríguez-Merchán EC, Oussedik S, editores. Total Knee Arthroplasty: A Comprehensive Guide. Springer International Publishing; 2015.

  BACKGROUND

• Maradit Kremers H, Visscher SL, Moriarty JP, Reinalda MS, Kremers WK, Naessens JM, Lewallen DG. Determinants of direct medical costs in primary and revision total knee arthroplasty. Clin Orthop Relat Res. 2013 Jan;471(1):206-14. doi: 10.1007/s11999-012-2508-z.

  PMID: 22864619 BACKGROUND

• Coles T, Williams V, Dwyer K, Mordin M. Psychometric Evaluation of the Patient's Knee Implant Performance Questionnaire. Value Health. 2018 Nov;21(11):1305-1312. doi: 10.1016/j.jval.2018.05.006. Epub 2018 Jun 30.

  PMID: 30442278 BACKGROUND

• Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.

  PMID: 22000572 BACKGROUND

• Rousseau MA, Lazennec JY, Catonne Y. Early mechanical failure in total knee arthroplasty. Int Orthop. 2008 Feb;32(1):53-6. doi: 10.1007/s00264-006-0276-7. Epub 2006 Nov 21.

  PMID: 17119961 BACKGROUND

• Ito H, Ichihara K, Tamari K, Amano T, Tanaka S, Uchida S. Factors characterizing gait performance of patients before and soon after knee arthroplasty. J Phys Ther Sci. 2021 Mar;33(3):274-282. doi: 10.1589/jpts.33.274. Epub 2021 Mar 17.

  PMID: 33814716 BACKGROUND

• Ro DH, Han HS, Lee DY, Kim SH, Kwak YH, Lee MC. Slow gait speed after bilateral total knee arthroplasty is associated with suboptimal improvement of knee biomechanics. Knee Surg Sports Traumatol Arthrosc. 2018 Jun;26(6):1671-1680. doi: 10.1007/s00167-017-4682-8. Epub 2017 Aug 28.

  PMID: 28849392 BACKGROUND

• Rosello Anon A, Martinez Garrido I, Cervera Deval J, Herrero Mediavilla D, Sanchez Gonzalez M, Vicent Carsi V. Total ankle replacement in patients with end-stage ankle osteoarthritis: clinical results and kinetic gait analysis. Foot Ankle Surg. 2014 Sep;20(3):195-200. doi: 10.1016/j.fas.2014.04.002. Epub 2014 Apr 18.

  PMID: 25103708 BACKGROUND

• San Martin Valenzuela C, Tabares-Seisdedos R, Paya Rubio A, Correa-Ghisays P, Pedrero-Sanchez JF, Silvestre Munoz A. Efficiency assessment of follow-up methodology of patients with knee replacement to predict post-surgical functionality: a protocol for randomised control PROKnee trial. BMJ Open. 2024 May 7;14(5):e077942. doi: 10.1136/bmjopen-2023-077942.

  PMID: 38719321 DERIVED

Study Officials

• Antonio Silvestre Muñoz, PhD.

  Orthopedic Surgery and Traumatology Service of the University Clinical Hospital of Valencia, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study participants, researchers who perform the functional assessments, and data analyst are unaware of the type of prosthetic stabilization used. They will not have access to the hospital medical history where the surgical procedure will be specified. The two surgeons in the study know the type of prosthesis used in each patient, and if the patient requests it, the technical specifications of the stabilization used are disclosed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and Head of the Orthopedic Surgery and Traumatology Service in Valencia University Clinical Hospital

Model Details: This study describes a prospective triple-blinded, randomized, controlled trial.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 20, 2021
• Study Start: September 27, 2021
• Primary Completion: July 28, 2023
• Study Completion: July 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)