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.
I. Objectives Due to the information reviewed, this research project has the following aims: 1. To determine the effectiveness of two different prosthesis stabilization procedures of TKA on the functionality achieved and perceived by the patient, as well as on the knee joint biomechanics during movement in activities of daily life. 2. 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 knee replacements. II. General procedures The study has the approval of the Ethical Committee for Research with Drugs of the University Clinical Hospital of Valencia. Likewise, this study will be conducted at the University Clinical Hospital of Valencia with the INCLIVA Health Research Institute and the University of Valencia (Spain). All assessment procedures will be performed at the Evaluation Unit in Personal Autonomy, Dependence, and Mental Disorders of the Faculty of Medicine at the University of Valencia. III. Methodology III.1. Study design The PROKnee trial was designed as a randomized, controlled, and triple-blinded (patient, raters, and data analysts) with two parallel groups. III.2 Participants 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. III.3 Assessment and Outcomes The study participants will be evaluated in five periods of evolution: before surgery, immediately after surgery, at 3 months of evolution, at 6 months of evolution, and a year after having performed the surgery. The set of tests to be carried out in each evaluation time and the data to be recorded are the following: Personal and Anthropometric data: * Age (years), Sex (men/women), Gender, BMI (kg/m2), race, level of education, marital status, height, weight, number of chronic diseases besides osteoarthritis, length of inferior extremities measured weight-bearing from the anterior iliac spine (AIS) to the medial malleolus, % of body fat, % of body water. * Chronicity of knee symptoms; Diagnosis, Surgical approach, Prosthetic implant, Side of surgery, Days of hospital stay, Leg swelling evaluation with thigh and calf circumference, Hospital readmission, Post-cx complications, Fall Incidence. Assessment scales: * To assess knee and other joint pain it will be used the Visual Analog Scale (EVA). * To assess knee function it will be used the Knee Osteoarthritis Outcome Score (KOOS). * To assess pain, stiffness, and function it will be used the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). * To assess physical activity it will be used the University of California, Los Angeles Physical Activity Questionnaire (UCLA). * To assess health-related quality of life it will be used the EuroQol Group 5-dimensions-Level 5 (EQ5D5L) and the Short Form-12 Physical Functioning (SF-12). * To assess cognitive state it will be used the Screen for Cognitive Impairment in Psychiatry (SCIP). * To assess joint awareness it will be used the Forgotten joint score-12 (FJS-12). * To assess anxiety and depression it will be used the Hospital Anxiety and Depression Scale (HADS). Radiological and Laboratory tests: * Imaging tests by radiography on the operated knee * Carrying out computed tomography in cases of inadequate function, to identify possible causes, without subjecting the patients to excessive irradiation. * Determination of Serum Levels of inflammatory biomarkers status: Interleukin-6, procalcitonin, calprotectin, and C-reactive protein. * Determination of intra-joint biomarkers: C-reactive protein, and alpha-defensin. Biomechanical functional assessment: * Range of motion in both knees. * Isometric knee strength flexion and extension of the operated and contralateral knee. * Lower limb proprioception. * Balance assessment during standing position. * Kinematic assessment of the lower limb during 1) Six-minute walking test gait, 2) Timed up-and-go test, 3) Gait, 4) Sit to stand Test, 5) Step-over, 6) Stepping up and down stairs. III.4 Intervention Participants will be randomized and allocated into two groups: 1) participants with a prosthesis with medial condylar stabilization and, 2) participants with a traditional prosthesis with central pivot stabilization. III.5 Sample size, recruitment, and randomization The sample size was estimated based on previous works that compare the medial stabilization knee prosthesis with another device. A small-medium effect (f = 0.15), a statistical significance of 5% at the two-tailed level, and a power of 90% are set, which gives a total of 82 people to be recruited. If 20% of the possible dropouts are considered, the initial recruitment will be of 99 people. Because patient recruitment will occur over a prolonged period, the assignment to the groups will be performed as block randomization with a 1:1 allocation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
99
Surgery will be done of Total knee prosthesis with medial condylar stabilization
Surgery will be done of Total knee prosthesis with central pivot stabilization
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, Spain
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.
Time frame: 1 year
Self-reported pain
Measured with the Visual Analog Scale (EVA). High scores indicate higher pain sensations.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
Cognitive status
Measured with the Screen for Cognitive Impairment in Psychiatry (SCIP) batery. High scores indicate better cognitive performance.
Time frame: 1 year
Range of motion
Active knee range of motion (º) and Passive knee range of motion (º) measured with a manual goniometer.
Time frame: 1 year
Muscle strength
Maximum muscle strength during knee flexion (N) and Maximum muscle strength during knee extension (N) registered with an electronic dynamometer.
Time frame: 1 year
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.
Time frame: 1 year
Gait speed during the Six-minute walking test
Distance traveled by the body in six minutes (m·s-1).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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)
Time frame: 1 year
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)
Time frame: 1 year
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).
Time frame: 1 year
Total execution time of Timed up and go test
Time spent by the person evaluated to perform the test (s)
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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)
Time frame: 1 year
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)
Time frame: 1 year
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).
Time frame: 1 year
Gait speed carried out in a 10-meter flat and unobstructed corridor
(ms-1)
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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)
Time frame: 1 year
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)
Time frame: 1 year
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)
Time frame: 1 year
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)
Time frame: 1 year
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)
Time frame: 1 year
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)
Time frame: 1 year
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)
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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