Total Knee Arthroplasty Clinical Trial
Official title:
Comparing Hybrid and Cemented TKA Using the NexGen LPS Prosthesis
Verified date | July 2018 |
Source | Hospital Galdakao-Usansolo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Early total knee arthroplasty (TKA) implant systems most frequently used an all-polyethylene
cemented tibial component1. Based on finite-element analysis studies reporting superior force
distribution compared with conventional all-polyethylene components, metal-backed tibial
baseplates have dominated the TKA implant market since the middle of the 1980's2. These
modular implants provided excellent long-term implant survivorship3.
As TKA became increasingly successful, younger patients increasingly became eligible.
Increasing life expectancy has raised the concern that cemented TKAs may not withstand
prolonged use, particularly in younger patients4. Patients younger than 65 years are
projected to account for more than 50% of patients undergoing TKA by 2016 and to more than
50% of patients undergoing revision surgery by 2011. The number of total knee revisions in
the United States is expected to increase from 38,300 in 2005 to 268,200 in 20305.
Many authors have reported excellent and equivalent results of cemented and cementless
TKA6-8. Despite these encouraging reports, the major concern with cementless TKA has been the
tibial component, and, therefore, the preference for many surgeons still remains to cement
the tibial component9,10. The femoral component may be the most suitable for cementless
fixation11-13. However, the best femoral method of fixation is still being discussed.
Currently, the decision to cement or not to cement the femoral component is based on the
surgeon's preference14.
The current study was designed to compare the hybrid NexGen LPS (Zimmer Inc, Warsaw, IN) and
the cemented NexGen LPS. The purpose of this study is to establish whether the hybrid NexGen
LPS leads to equally successful results as the cemented TKA gold standard
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | December 2026 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: Patients may be included in the study only if they meet the following criteria: - Patient is able to provide informed consent. - Patient is between 18 and 75 years of age. - Patients are willing and able to attend all follow-up visits and complete all study requirements. They must agree to comply with all study related procedure, including understanding and adhering to the rehabilitation protocol. - Patient has primary or secondary knee osteoarthritis. - Patient has sufficient bone quality for total knee arthroplasty. - Patient is in stable health. - Female patients are not pregnant at times of surgery and do not plan on becoming pregnant during the study. Note: patient can only enter the project with one knee Exclusion Criteria: - Neuromuscular or vascular disease in the affected leg. - Patients with osteoporosis based on former diagnosis or preoperative DEXA-scan. - Fracture sequelae or previous HTO or previous extensive knee surgery. - Patients with need of a stem-elongation. - Patients who cannot refrain from taking NSAID post-operatively. - Patients with metabolic bone disease. - Patients with renal disease. - Patients with rheumatoid arthritis. - Postmenopausal women in estrogenic hormone substitution - Patients with a continuous need of systemic cortisone treatment. - Non-Spanish citizenship. - Patients who do not comprehend the Spanish language (read and speak). - Senile dementia. - Alcohol abuse - defined as men drinking more than 21 units a week and women drinking more than 14 units a week. - Drug abuse. - Major psychiatric disease. - Metastatic cancer disease and treatment with radiation therapy or chemotherapy |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Galdakao-Usansolo | Galdakao | Bizkaia |
Lead Sponsor | Collaborator |
---|---|
Jesus Moreta Suarez |
Spain,
Carlsson A, Björkman A, Besjakov J, Onsten I. Cemented tibial component fixation performs better than cementless fixation: a randomized radiostereometric study comparing porous-coated, hydroxyapatite-coated and cemented tibial components over 5 years. Act — View Citation
Dunbar MJ, Wilson DA, Hennigar AW, Amirault JD, Gross M, Reardon GP. Fixation of a trabecular metal knee arthroplasty component. A prospective randomized study. J Bone Joint Surg Am. 2009 Jul;91(7):1578-86. doi: 10.2106/JBJS.H.00282. — View Citation
Huddleston JI, Wiley JW, Scott RD. Zone 4 femoral radiolucent lines in hybrid versus cemented total knee arthroplasties: are they clinically significant? Clin Orthop Relat Res. 2005 Dec;441:334-9. — View Citation
Illgen R, Tueting J, Enright T, Schreibman K, McBeath A, Heiner J. Hybrid total knee arthroplasty: a retrospective analysis of clinical and radiographic outcomes at average 10 years follow-up. J Arthroplasty. 2004 Oct;19(7 Suppl 2):95-100. — View Citation
Nilsson KG, Kärrholm J, Carlsson L, Dalén T. Hydroxyapatite coating versus cemented fixation of the tibial component in total knee arthroplasty: prospective randomized comparison of hydroxyapatite-coated and cemented tibial components with 5-year follow-u — View Citation
Uvehammer J, Kärrholm J, Carlsson L. Cemented versus hydroxyapatite fixation of the femoral component of the Freeman-Samuelson total knee replacement: a radiostereometric analysis. J Bone Joint Surg Br. 2007 Jan;89(1):39-44. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative functional outcome as measured by the Knee and Osteoarthritis Outcome Score (KOOS) and compare if hybrid NexGen LPS TKA leads to equally successful results as the cemented NexGen LPS TKA. | The current study will be designed as equivalence trial. The amount of allowable difference is the margin that defines the "zone of indifference" within which the interventions are considered equivalent. The KOOS has a Minimally Clinically Important Difference (MCID) of 8 - 10 points, and the standard deviation in a cohort of TKA patients is ca. 15 points. The null hypothesis (of non-equivalence) of the study is that functional outcome at 10 years of follow-up in the hybrid group is not equal to the functional outcome at 10 years of follow-up in the cemented group, or: H: ? = ?0 - d1 or ? = ?0 + d1, versus the equivalence assumption that functional outcome at 10 years of follow-up in the hybrid group is equivalent to the functional outcome at 10 years of follow-up in the cemented group: K: ?0 - d1 < ? < ?0 + d1. |
1 year | |
Secondary | Incidence and extend of radiolucent lines (RLL) as measured by standard radiography. | Radiography: x-rays will be taken during visit 4 and visits 7-10. Conventional anteroposterior and lateral radiographs will be taken at designated time-points. In order to obtain "true orthogonal" radiographs and to reduce the probability of false-negative findings, the lateral image will be obtained under fluoroscopic control. Postoperative radiographs will assess component position and alignment, the incidence and location of radiolucent lines using the Knee Society TKA radiographic evaluation system. | Up to 10 years. | |
Secondary | Postoperative functional outcome as measured by Knee Society Score. | The KSS is a questionnaire validate in Spanish.The study regimen for each patient will consist of a screening / baseline phase (Visit 1), follow-up visits (Visits 3 - 9) and a conclusion visit (Visit 10). All procedures specified in this protocol must be documented in the patient's record and on the corresponding Case Report Form (CRF). | up until 10 years of follow up |
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