Total Knee Arthroplasty Clinical Trial
— PROkneeOfficial title:
Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses
Verified date | February 2024 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 99 |
Est. completion date | July 2024 |
Est. primary completion date | July 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | The inclusion criteria are: - People between 50-85 years old and, - Primary total knee prosthesis surgery indication with patellar fitting. The exclusion criteria are as follows: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Orthopedic Surgery and Traumatology Service of the University Clinical Hospital of Valencia | Valencia | |
Spain | Unidad de Evaluación en Autonomía Personal, Dependencia y Trastornos Mentales Graves (TMAP), University of Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia | INCLIVA |
Spain,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.
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. — View Citation
Rodríguez-Merchán EC, Oussedik S, editores. Total Knee Arthroplasty: A Comprehensive Guide. Springer International Publishing; 2015.
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Self-reported pain | Measured with the Visual Analog Scale (EVA). High scores indicate higher pain sensations. | 1 year | |
Secondary | Self-reported knee function - Knee Osteoarthritis Outcome Score | Measured with the Knee Osteoarthritis Outcome Score (KOOS). It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. | 1 year | |
Secondary | Self-reported knee function - Western Ontario and McMaster Universities Osteoarthritis Index | Measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It is consisted of 33 items which evaluates the health and function of the patient from various aspects. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores are representative of better situation and less pain. | 1 year | |
Secondary | Self-reported Physical activity | Measured with the University of California, Los Angeles Physical Activity Questionnaire (UCLA). UCLA is a single-item 10-level-scale, ranging from level 10, representing a highly physically active patient, to level 1, a patient who is dependent on others and unable to leave home. | 1 year | |
Secondary | Joint awareness | Measured with the Forgotten joint score-12 (FJS-12) questionnaire; indicates the degree of discomfort that the patient perceives in the activities of daily living produced by the knee pathology. The FJS-12 contains 12 questions which are scored with a Likert scale ranging from 0 to 4. A lower score on the Likert scale equates to less awareness of the joint. | 1 year | |
Secondary | Health-related quality of life - EuroQol Group 5-dimensions-Level 5 | Measured with the EuroQol Group 5-dimensions-Level 5 (EQ5D5L). The test covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with 5 levels of severity in each dimension (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). Low scores on each item indicate a good perception of health. | 1 year | |
Secondary | Health-related quality of life - Short Form-12 Physical Functioning | Measured with the Short Form-12 Physical Functioning (SF-12). A higher score indicates higher levels of quality of life. | 1 year | |
Secondary | Mental status | Anxiety and depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. | 1 year | |
Secondary | Cognitive status | Measured with the Screen for Cognitive Impairment in Psychiatry (SCIP) batery. High scores indicate better cognitive performance. | 1 year | |
Secondary | Range of motion | Active knee range of motion (º) and Passive knee range of motion (º) measured with a manual goniometer. | 1 year | |
Secondary | Muscle strength | Maximum muscle strength during knee flexion (N) and Maximum muscle strength during knee extension (N) registered with an electronic dynamometer. | 1 year | |
Secondary | Lowe limb proprioception | Measured by the number of degrees that the patient makes when equalizing a certain position with their legs. The more degrees of difference, the less proprioception the person being evaluated presents. Will be measured with the Physiological Profile Assessment tool. | 1 year | |
Secondary | Gait speed during the Six-minute walking test | Distance traveled by the body in six minutes (m·s-1). | 1 year | |
Secondary | Vertical range displacement of the Center of Masses during the Six-minute walking test | Range of vertical movement (displacement) performed by the center of mass during the test (mm). | 1 year | |
Secondary | Medial-lateral range displacement of the Center of Masses during the Six-minute walking test | Range of lateral movement (displacement) performed by the center of mass during the test (mm). | 1 year | |
Secondary | Medial-lateral Jerk during the Six-minute walking test | Lateral change rate of acceleration taken by the measured person while performing the test (m/s3) | 1 year | |
Secondary | Anterior-posterior Jerk during the Six-minute walking test | Anterior-posterior change rate of acceleration taken by the measured person while performing the test (m/s3) | 1 year | |
Secondary | Power Spectral Density in turning during the Six-minute walking test | Distribution of movement power over the frequency bands associated with movement during the trial (W/Hz). | 1 year | |
Secondary | Total execution time of Timed up and go test | Time spent by the person evaluated to perform the test (s) | 1 year | |
Secondary | Vertical range displacement of the Center of Masses during Timed up and go test | Range of vertical movement (displacement) performed by the center of mass during the test (mm). | 1 year | |
Secondary | Medial-lateral range displacement of the Center of Masses during Timed up and go test | Range of lateral movement (displacement) performed by the center of mass during the test (mm). | 1 year | |
Secondary | Medial-lateral Jerk during Timed up and go test | Lateral change rate of acceleration taken by the measured person while performing the test (m/s3) | 1 year | |
Secondary | Anterior-posterior Jerk during Timed up and go test | Anterior-posterior change rate of acceleration taken by the measured person while performing the test (m/s3) | 1 year | |
Secondary | Power Spectral Density in turning during Timed up and go test | Distribution of movement power over the frequency bands associated with movement during the trial (W/Hz). | 1 year | |
Secondary | Gait speed carried out in a 10-meter flat and unobstructed corridor | (ms-1) | 1 year | |
Secondary | Stride length during gait | Distance traveled by the person measured from the heel contact of one leg to the next heel contact of the same leg; measured in a 10-meter flat and unobstructed corridor with a 3D photogrammetry system and two dynamometric platforms (m). | 1 year | |
Secondary | Cadence during gait | Number of the steps calculated in a minute, measured in a 10-meter flat and unobstructed corridor with a 3D photogrammetry system and two dynamometric platforms (steps/min). | 1 year | |
Secondary | Stance time during gait | Percentage of the gait cycle that lasts the stance phase measured in a 10-meter flat and unobstructed corridor with a 3D photogrammetry system and two dynamometric platforms (% gait cycle). | 1 year | |
Secondary | Maximum knee extension during the stance phase of gait | Maximum knee extension achieved during the stance phase of gait measured in a 10-meter flat and unobstructed corridor with a 3D photogrammetry system (º). | 1 year | |
Secondary | Maximum knee flexion during the swing phase of gait | Maximum knee flexion achieved during the swing phase of gait measured in a 10-meter flat and unobstructed corridor with a 3D photogrammetry system (º). | 1 year | |
Secondary | Ground reaction force during weight acceptance of gait cycle | First peak of vertical force during stance phase of gait measured in a 10-meter flat and unobstructed corridor with a system of two dynamometric platforms (N). | 1 year | |
Secondary | Ground reaction force during toe-off of gait cycle | Second peak of vertical force during stance phase of gait measured in a 10-meter flat and unobstructed corridor with a system of two dynamometric platforms (N). | 1 year | |
Secondary | Maximum vertical force during Sit-to-stand test | Maximum vertical force of prosthetic leg and no-operated leg, calculated for sitting and standing phases separately; measured with a system of two dynamometric platforms (N). | 1 year | |
Secondary | Knee momentum during Sit-to-stand test | Product of knee mass and speed of movement performed for the prosthetic knee and no-operated knee, calculated for sitting and standing phases separately; measured with a 3D photogrammetry system (Nm). | 1 year | |
Secondary | Knee range of motion during Sit-to-stand test | Range of motion achieved by the prosthetic knee and no-operated knee, calculated for sitting and standing phases separately; measured with a 3D photogrammetry system (º). | 1 year | |
Secondary | Knee angular velocity during Sit-to-stand test | Rate of change of angular position with respect to time of the prosthetic knee and no-operated knee, calculated for sitting and standing phases separately; measured with a 3D photogrammetry system (º/seg). | 1 year | |
Secondary | Maximum vertical ground reaction force in the single stance of the Step-over test | Maximum vertical ground reaction force in the single stance over the step for the prosthetic and no-operated knee, measured with a system of two dynamometric platforms (N) | 1 year | |
Secondary | Maximum vertical ground reaction force in landing phase of the Step-over test | Maximum vertical ground reaction force in landing for the prosthetic and no-operated knee, measured with a system of two dynamometric platforms (N) | 1 year | |
Secondary | Knee momentum during the single stance phase of the Step-over test | Product of knee mass and speed of movement performed during the single stance step for the prosthetic and no-operated knee, measured with a 3D photogrammetry system (Nm) | 1 year | |
Secondary | Knee range of motion Step-over test | Range of motion achieved during the trial for the prosthetic and no-operated knee, measured with a 3D photogrammetry system (º) | 1 year | |
Secondary | Knee angular velocity during swing phase of the Step-over test | Rate of change of angular position with respect to time for the prosthetic and no-operated knee, during the swing phase of step over, measured with a 3D photogrammetry system (º/s) | 1 year | |
Secondary | Maximum knee flexion from Stepping up and down stairs test | Maximum knee flexion during up and down for the prosthetic and no-operated knee and measured with a 3D photogrammetry system (º) | 1 year | |
Secondary | Knee angular velocity from Stepping up and down stairs test | Rate of change of angular position with respect to time during up and down, for the prosthetic and no-operated knee and measured with a 3D photogrammetry system (º/s) | 1 year | |
Secondary | Maximum vertical ground reaction force in single support from Stepping up and down stairs test | Maximum vertical ground reaction force in single support during up and down for the prosthetic and no-operated knee and measured with two dynamometric platforms (N). | 1 year | |
Secondary | Flexion/extension knee momentum in up and down from Stepping up and down stairs test | Product of knee mass and speed of movement performed for the prosthetic and no-operated knee and measured with a 3D photogrammetry system (Nm). | 1 year | |
Secondary | Varus/valgus knee momentum during up and down from Stepping up and down stairs test | Product of knee mass and speed of movement performed for the prosthetic and no-operated knee and measured with a 3D photogrammetry system (Nm). | 1 year |
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 | |
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 | |
Active, not recruiting |
NCT05018091 -
Dexamethasone in Total Knee Arthroplasty
|
Phase 4 |