Clinical trial NCT02798432: Hybrid Versus Cemented TKA Using the NexGen LPS Prosthesis
Official title: Comparing Hybrid and Cemented TKA Using the NexGen LPS Prosthesis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty
Hybrid
Cemented
Fixation
Lead sponsor: Hospital Galdakao-Usansolo
Sponsor class: OTHER_GOV
First posted: 2016-06-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Incidence and extend of radiolucent lines (RLL) as measured by standard radiography.
timeFrame: Up to 10 years.
measure: Postoperative functional outcome as measured by Knee Society Score.
timeFrame: up until 10 years of follow up
Other outcomes:
Locations:
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Bizkaia
Study officials:
affiliation: Hospital Galdakao-Usansolo
name: Jesus Moreta, MD, FEBOT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson KG, Karrholm J, Carlsson L, Dalen 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-up using radiostereometry. J Arthroplasty. 1999 Jan;14(1):9-20. doi: 10.1016/s0883-5403(99)90196-1.
citation: Carlsson A, Bjorkman 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. Acta Orthop. 2005 Jun;76(3):362-9.
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. doi: 10.1097/01.blo.0000180452.11048.b8.
citation: Uvehammer J, Karrholm 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. doi: 10.1302/0301-620X.89B1.17974.
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. doi: 10.1016/j.arth.2004.06.022.
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.