Total Knee ArthroplastyPhase 3PROkneeNCT04850300
Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses
A Phase 3 study testing Total knee prosthesis with medial condylar stabilization and Total knee prosthesis with central pivot stabilization in people with Total Knee Arthroplasty, run by University of Valencia at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Total knee prosthesis with medial condylar stabilization and Total knee prosthesis with central pivot stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesSpain
- Study dates
- 27 Sep 2021to Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Orthopedic Surgery and Traumatology Service of the University Clinical Hospital of Valencia
Valencia, 46010
Unidad de Evaluación en Autonomía Personal, Dependencia y Trastornos Mentales Graves (TMAP), University of Valencia
Valencia, 46010
About this study
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.
Read the detailed description
- Objectives
Due to the information reviewed, this research project has the following aims:
- 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.
- 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Total knee prosthesis with medial condylar stabilization, Total knee prosthesis with central pivot stabilization
- Keywords
- Total knee arthroplasty, Functional assessment, Prognosis biomarkers, Medial condylar stabilization, Central pivot stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee prosthesis with medial condylar stabilizationProcedure or surgery
Surgery will be done of Total knee prosthesis with medial condylar stabilization
Total knee prosthesis with central pivot stabilizationProcedure or surgery
Surgery will be done of Total knee prosthesis with central pivot stabilization
| Study group | Role | What they receive |
|---|---|---|
| Total knee prosthesis 1 | Experimental | prosthesis with medial condylar stabilization Receives: Procedure: Total knee prosthesis with medial condylar stabilization |
| Total knee prosthesis 2 | Active comparator | traditional prosthesis with central pivot stabilization Receives: Procedure: Total knee prosthesis with central pivot stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (46)
Self-reported pain
Measured with the Visual Analog Scale (EVA). High scores indicate higher pain sensations.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Cognitive status
Measured with the Screen for Cognitive Impairment in Psychiatry (SCIP) batery. High scores indicate better cognitive performance.
Measured: 1 year
Range of motion
Active knee range of motion (º) and Passive knee range of motion (º) measured with a manual goniometer.
Measured: 1 year
Muscle strength
Maximum muscle strength during knee flexion (N) and Maximum muscle strength during knee extension (N) registered with an electronic dynamometer.
Measured: 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.
Measured: 1 year
Gait speed during the Six-minute walking test
Distance traveled by the body in six minutes (m·s-1).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 1 year
Total execution time of Timed up and go test
Time spent by the person evaluated to perform the test (s)
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 1 year
Gait speed carried out in a 10-meter flat and unobstructed corridor
(ms-1)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start27 Sep 2021
- Primary completion28 Jul 2023
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study describes a prospective triple-blinded, randomized, controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria INCLIVA
- Responsible party
- Principal investigator, Antonio Silvestre, Instituto de Investigacion Sanitaria INCLIVA
- Investigators
- Antonio Silvestre Muñoz, PhD., Principal investigator, Orthopedic Surgery and Traumatology Service of the University Clinical Hospital of Valencia, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850300
- Sponsor's protocol ID
- 2020/181
- Acronym
- PROknee
- Status last verified
- Feb 2024
- First submitted
- 8 Apr 2021
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Rodríguez-Merchán EC, Oussedik S, editores. Total Knee Arthroplasty: A Comprehensive Guide. Springer International Publishing; 2015.
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.
PubMed 22864619Coles 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.
PubMed 30442278Behrend 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.
PubMed 22000572Rousseau 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.
PubMed 17119961Ito 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.
PubMed 33814716Ro 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.
PubMed 28849392Rosello 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.
PubMed 25103708San 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.
PubMed 38719321
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses
- ClinicalTrials.gov ID
- NCT04850300
- Acronym / sponsor ID
- PROknee / 2020/181
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty, Functional assessment, Prognosis biomarkers, Medial condylar stabilization, Central pivot stabilization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria INCLIVA
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- Jul 2024 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Objectives
Due to the information reviewed, this research project has the following aims:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study describes a prospective triple-blinded, randomized, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Total knee prosthesis 1 | Experimental | Procedure: Total knee prosthesis with medial condylar stabilizationprosthesis with medial condylar stabilization |
| Total knee prosthesis 2 | Active comparator | Procedure: Total knee prosthesis with central pivot stabilizationtraditional prosthesis with central pivot stabilization |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee prosthesis with medial condylar stabilizationSurgery will be done of Total knee prosthesis with medial condylar stabilization | Procedure or surgery | Total knee prosthesis 1 |
| Total knee prosthesis with central pivot stabilizationSurgery will be done of Total knee prosthesis with central pivot stabilization | Procedure or surgery | Total knee prosthesis 2 |
Primary outcome
Maximum walking speed (MWS)
Time frame: 1 year
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.
46 secondary outcomes
Self-reported pain
Time frame: 1 year
Self-reported knee function - Knee Osteoarthritis Outcome Score
Time frame: 1 year
Self-reported knee function - Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 1 year
Self-reported Physical activity
Time frame: 1 year
Joint awareness
Time frame: 1 year
Health-related quality of life - EuroQol Group 5-dimensions-Level 5
Time frame: 1 year
Health-related quality of life - Short Form-12 Physical Functioning
Time frame: 1 year
Mental status
Time frame: 1 year
Cognitive status
Time frame: 1 year
Range of motion
Time frame: 1 year
Muscle strength
Time frame: 1 year
Lowe limb proprioception
Time frame: 1 year
Gait speed during the Six-minute walking test
Time frame: 1 year
Vertical range displacement of the Center of Masses during the Six-minute walking test
Time frame: 1 year
Medial-lateral range displacement of the Center of Masses during the Six-minute walking test
Time frame: 1 year
Medial-lateral Jerk during the Six-minute walking test
Time frame: 1 year
Anterior-posterior Jerk during the Six-minute walking test
Time frame: 1 year
Power Spectral Density in turning during the Six-minute walking test
Time frame: 1 year
Total execution time of Timed up and go test
Time frame: 1 year
Vertical range displacement of the Center of Masses during Timed up and go test
Time frame: 1 year
Medial-lateral range displacement of the Center of Masses during Timed up and go test
Time frame: 1 year
Medial-lateral Jerk during Timed up and go test
Time frame: 1 year
Anterior-posterior Jerk during Timed up and go test
Time frame: 1 year
Power Spectral Density in turning during Timed up and go test
Time frame: 1 year
Gait speed carried out in a 10-meter flat and unobstructed corridor
Time frame: 1 year
Stride length during gait
Time frame: 1 year
Cadence during gait
Time frame: 1 year
Stance time during gait
Time frame: 1 year
Maximum knee extension during the stance phase of gait
Time frame: 1 year
Maximum knee flexion during the swing phase of gait
Time frame: 1 year
Ground reaction force during weight acceptance of gait cycle
Time frame: 1 year
Ground reaction force during toe-off of gait cycle
Time frame: 1 year
Maximum vertical force during Sit-to-stand test
Time frame: 1 year
Knee momentum during Sit-to-stand test
Time frame: 1 year
Knee range of motion during Sit-to-stand test
Time frame: 1 year
Knee angular velocity during Sit-to-stand test
Time frame: 1 year
Maximum vertical ground reaction force in the single stance of the Step-over test
Time frame: 1 year
Maximum vertical ground reaction force in landing phase of the Step-over test
Time frame: 1 year
Knee momentum during the single stance phase of the Step-over test
Time frame: 1 year
Knee range of motion Step-over test
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- BackgroundPoley 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.
- BackgroundRodríguez-Merchán EC, Oussedik S, editores. Total Knee Arthroplasty: A Comprehensive Guide. Springer International Publishing; 2015.
- Background: PubMed 22864619Maradit 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.
- Background: PubMed 30442278Coles 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.
- Background: PubMed 22000572Behrend 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.
- Background: PubMed 17119961Rousseau 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.
- Background: PubMed 33814716Ito 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.
- Background: PubMed 28849392Ro 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.
- Background: PubMed 25103708Rosello 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.
- Derived from this study: PubMed 38719321San 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Silvestre Muñoz, PhD. principal investigator
Orthopedic Surgery and Traumatology Service of the University Clinical Hospital of Valencia, Spain.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Total knee prosthesis with medial condylar stabilization and Total knee prosthesis with central pivot stabilization in people with Total Knee Arthroplasty, run by University of Valencia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum walking speed (MWS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04850300, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.