Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses
试验速览
- 阶段
- 3 期
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Maximum walking speed (MWS)
研究概览
简要总结
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.
详细描述
I. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are:
- •People between 50-85 years old and,
- •Primary total knee prosthesis surgery indication with patellar fitting.
排除标准
- •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.
研究组 & 干预措施
Total knee prosthesis 1
prosthesis with medial condylar stabilization
干预措施: Total knee prosthesis with medial condylar stabilization (Procedure)
Total knee prosthesis 2
traditional prosthesis with central pivot stabilization
干预措施: Total knee prosthesis with central pivot stabilization (Procedure)
结局指标
主要结局
Maximum walking speed (MWS)
时间窗: 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.
次要结局
- Total execution time of Timed up and go test(1 year)
- Self-reported knee function - Knee Osteoarthritis Outcome Score(1 year)
- Self-reported pain(1 year)
- Muscle strength(1 year)
- Health-related quality of life - EuroQol Group 5-dimensions-Level 5(1 year)
- Cognitive status(1 year)
- Health-related quality of life - Short Form-12 Physical Functioning(1 year)
- Range of motion(1 year)
- Medial-lateral range displacement of the Center of Masses during Timed up and go test(1 year)
- Gait speed carried out in a 10-meter flat and unobstructed corridor(1 year)
- Cadence during gait(1 year)
- Maximum knee extension during the stance phase of gait(1 year)
- Ground reaction force during weight acceptance of gait cycle(1 year)
- Ground reaction force during toe-off of gait cycle(1 year)
- Knee range of motion Step-over test(1 year)
- Lowe limb proprioception(1 year)
- Vertical range displacement of the Center of Masses during the Six-minute walking test(1 year)
- Medial-lateral range displacement of the Center of Masses during the Six-minute walking test(1 year)
- Vertical range displacement of the Center of Masses during Timed up and go test(1 year)
- Anterior-posterior Jerk during Timed up and go test(1 year)
- Stride length during gait(1 year)
- Maximum knee flexion during the swing phase of gait(1 year)
- Knee angular velocity from Stepping up and down stairs test(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)
- Mental status(1 year)
- Gait speed during the Six-minute walking test(1 year)
- Power Spectral Density in turning during the Six-minute walking test(1 year)
- Power Spectral Density in turning during Timed up and go test(1 year)
- Stance time during gait(1 year)
- Maximum vertical force during Sit-to-stand test(1 year)
- Knee momentum during Sit-to-stand test(1 year)
- Maximum vertical ground reaction force in landing phase of the Step-over test(1 year)
- Medial-lateral Jerk during the Six-minute walking test(1 year)
- Anterior-posterior Jerk during the Six-minute walking test(1 year)
- Medial-lateral Jerk during Timed up and go test(1 year)
- Knee range of motion during Sit-to-stand test(1 year)
- Maximum vertical ground reaction force in the single stance of the Step-over test(1 year)
- Knee momentum during the single stance phase of the Step-over test(1 year)
- Maximum knee flexion from Stepping up and down stairs test(1 year)
- Knee angular velocity during Sit-to-stand test(1 year)
- Knee angular velocity during swing phase of the Step-over test(1 year)
- Varus/valgus knee momentum during up and down from Stepping up and down stairs test(1 year)
- Maximum vertical ground reaction force in single support from Stepping up and down stairs test(1 year)
- Flexion/extension knee momentum in up and down from Stepping up and down stairs test(1 year)
研究者
Antonio Silvestre
Researcher and Head of the Orthopedic Surgery and Traumatology Service in Valencia University Clinical Hospital
Instituto de Investigacion Sanitaria INCLIVA