Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
68 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-04-01
Study Completion Date
2019-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A prospective randomized controlled study evaluating the wear and migration of cemented acetabular sockets with third generation highly cross-linked vitamin E infused polyethylene and second generation highly crosslinked UHMWPE using Radiostereometric Analysis (RSA).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty
NCT02254980
Total Hip Arthroplasty
ACTIVE_NOT_RECRUITING
NA
Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement
NCT02524587
Total Hip Replacement
UNKNOWN
NA
Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.
NCT00804388
Primary Arthrosis
Osteoarthritis
UNKNOWN
NA
Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
NCT05175300
Hip Arthropathy
RECRUITING
NA
Study of the Clinical and Radiographic Results of a Fixed Polyethylene Posteriorly Stabilized Cemented Total Knee Prosthesis With a Minimum Follow-up of 1 Year.
NCT07313449
Hip Osteoarthritis
RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background Reducing the rate of polyethylene (PE) wear in acetabular sockets and thereby increasing the lifespan of Total Hip Arthroplasty (THA) has been a major concern in the orthopaedic community for decades. Wear of PE and osteolysis followed by late aseptic loosening of the prosthesis is the main reason for revision surgery after THA in Norway.
During 2008 in Norway 805 out of a total of 1114 revised THA were subjugated to surgery due to aseptic loosening or osteolysis without loosening. The DRG (Diagnose Related Grouping) weight is 5.49 for secondary THA and every DRG point has a value of 33.647 NOK adding up to a direct total cost for revision after aseptic loosening of approximately 27 million USD.
Caput prosthesis with a diameter of 32mm or more has the major advantage to increase the Range of Motion (ROM) and to reduce the risk of dislocation of the hip but, the larger the caput prosthesis the more adhesive wear can be expected. This and the relative failure of metal on PE gave the incentive to develop and take into clinical practise bearings with increased resilience to wear. Today, there exists a wide range of options with a substantially lower rate of volumetric wear compared to conventional PE. The biological and immunological in vivo response to wear particles is very complicated and only partially understood. It is clear that host response to wear particles and the corrosion products play a major role in osteolysis around the prosthesis. For metal-on-metal (MoM) bearings the volumetric wear is a magnitude less but the number of particle debris is massively increased. MoM also have the problem with possible teratogen effect and allergy or hypersensitivity side effects. Ceramic on ceramic (cer-cer) has the lowest wear rate of any artificial articulations, but it is still possible to detect biologically active debris particles. Cer-cer also has other challenges including fracture of prosthesis, squeaking hip, narrow margins for placing components and cost.
Polyethylene is a thermoplastic polymer consisting of long chains of the monomer ethylene (C2H4). The mechanical properties of PE depend on variables such as the extent and type of branching and the crystal structure etc.
To improve the wear resistance of the PE an increase in the cross-linking between the chains of polyethylene can be achieved by exposing it to high-energy irradiation. The irradiation also increases the unpaired free electrons (free radicals). Free radicals can react with oxygen and start a chain reaction causing an oxidative degradation of the polyethylene and consequently cause increased wear. 1st generation HXLPE sockets have reduced the mid term incidence of particle-induced osteolysis but retrieved failed first-generation HXLPE sockets have shown surface cracking and signs of in vivo oxidative degradation.
In order to enhance the resistance to mechanical fatigue and reduce oxidative potential 2nd generation HXLPE was developed. To reduce the oxidative potential the polyethylene can be remelted or annealed. Remelting aggravates the mechanical properties of the polyethylene and after annealing there are still remaining free radicals capable of oxidation in vivo. By binding to unpaired free electrons Vitamin E is a scavenger of free radicals. Vitamin E is hydrophobic and can thereby be infused into polyethylene. 3rd generation HXLPE is manufactured below the melting temperature to maintain its mechanical properties and contains Vitamin E to stabilize free radicals. Uncemented Acetabular HXLPE sockets have been shown to have substantially reduced volumetric wear and excellent clinical mid-term results with this type of PE. In Scandinavia the majority of sockets are cemented. The different principles of biological or mechanical stability affects the properties of the socket typically different E-module and the surrounding interface between implant and bone. Conventional PE cemented cups have performed better with less aseptic loosening than uncemented cups. However, as the mechanical properties are changed in highly cross-linked Polyethylene cups, it is not clear whether the higher elasticity of the bone-cement-polyethylene compound might lead to fractures of the more brittle polyethylene. It is therefore not possible to extrapolate clinical results and wear rates from uncemented cups to cemented ones.
Placement of the cup is a crucial parameter for wear and cup survival. Malchau et al. has shown that even high volume surgeons achieve suboptimal placement in 40% of cases. This may depend on patient positioning perioperative, surgical instruments or technique. It is not known whether the surgeon's subjective operative technique directly corresponds to the postoperative evaluation of the cups position. However, adequate cup positioning is crucial in the evaluation of wear. CT is the best method to judge cup position postoperatively and detect osteolysis in the long time perspective.
To the investigators knowledge no randomized controlled study of cemented 3rd generation HXLPE cups utilizing RSA has been conducted.
Hypothesis There is a mid term in vivo reduction of volumetric polyethylene wear with cemented acetabular socket 3rd generation E1™ HXLPE compared with 2nd generation HXLPE.
Material: 70 eligible patients will be included following written informed consent. The participants will be randomized by the envelope method to either E1™ or Marathon™ cemented acetabular socket. The surgery will be performed at the hospitals in Vestre Viken HF and Oslo University hospital HF, Ullevål ortopeden.
Implant The investigators will use two different cemented all PE acetabular sockets;
1. MarathonTM is a 1st generation HXLPE. The polyethylene is cross-linked with 5 Mrad that corresponds to a semi cross-linked PE.
2. The E1™ cemented is an all PE Vitamin E stabilized 3rd generation highly crosslinked UHMWPE. In vitro tests have shown a 99 % decreased volumetric wear rate comparing E1™ with ArComXL™ HXLPE, (highly crosslinked polyethylene) under high contact stress and a 95% reduction in wear rate comparing E1™ with ArCom™ under high contact area stress. Wear particle morphology of E1™ is similar to that of the ArCom™ material.
Collared Corail™ (De Puy, Warsaw, Indiana, USA) uncemented femoral prosthesis is a titanium tapered implant fully coated with 150 micron hydroxyapatite with over 95% survival after 15 years. The caput prosthesis used is the Cobalt Chrome 32 mm Articul/EZE™ (De Puy, Warsaw, Indiana, USA) Refobacin ™ (Biomet Europe, Berlin, Germany) Bone Cement R is a high viscosity, x-ray positive bone cement. A sachet of 40 g Refobacin® Bone Cement R contains 0.5 g gentamicin.
Surgical technique The patient is operated in the position after surgeon's preference and under spinal anaesthesia. Accordingly the approach is after surgeon's preference. When posterolateral approach is chosen a repair of the capsule and the external rotators should be performed. Peroperatively a total of 6 1,0mm tantalum beads are implanted in the perimeter of the socket and 7 beads in the acetabulum. The acetabular socket is positioned as close to 45◦ abduction and 30◦ anteversion as possible.
The surgeon will postoperative directly grade cup position subjectively as anteverted, neutral, retroverted, proximalized, distalized.
Postoperative training Postoperatively the patient is mobilized with full weight bearing from day one.
Radiological analyses Conventional x-ray of pelvis, anterioposterior and lateral projections of hip preoperatively, postoperatively and at 24 (60, 120) months RSA (Radiostereometric analysis) postoperatively, 3, 12, 24 (60, 120) months, the RSA will be analysed at Ullevål University Hospital
Clinical Control Harris Hip Score, EQ-5D and WOMAC will be filled out preoperatively and at 2, 5 and 10 years.
Analysis of data RSA analysis will be performed at the Centre of Implant and Radiostereometric Research Oslo (CIRRO).
The study analysis is conducted under the guidance of CIRRO.
Storage of data Data will be collected and stored at the server for research at Oslo University Hospital. All data is stored anonymously. Each patient receives a study ID. The randomisation key and identity is stored separately.
Statistics Penetration of more than 0,1 mm annually in polyethylene articulations indicates a wear rate that will lead to future osteolysis1.
Scientific value Firstly, if recently developed manufacturing techniques of polyethylene can be shown to decrease the wear rate in vivo, and otherwise have a good clinical and radiological outcome, we have the reason to believe we have the possibility of significantly reducing the revision rate after THA.
Secondly, new implants should thoroughly be investigated and documented before widespread use. This could save many patients from possible disastrous failures as the past has taught us (Boneloc, Carbon compressed Poly).
Safety for the patient. The investigators will follow the normal routines for THA pre, per and postoperatively. Standardized routines in regards to infection and thrombosis prophylaxis following the recommendations from the Norwegian national board of orthopaedics will be followed. Implantation of Tantalum beads has been shown to have negligible side effects.
The E1TM and Marathon PE is clinically tested in uncemented THA, the other components of the prosthesis has more than 10 years clinical and RSA documentation.
Biomet will cover expenses including:
Extra cost of purchasing and storing prosthesis compared with standard prosthesis. Biomet or Stryker has no copy right or any other form of ownership to the result of this study.
During 2008 in Norway 805 out of a total of 1114 revised THA were subjugated to surgery due to aseptic loosening or osteolysis without loosening. The DRG (Diagnose Related Grouping) weight is 5.49 for secondary THA and every DRG point has a value of 33.647 NOK adding up to a direct total cost for revision after aseptic loosening of approximately 27 million USD.
Caput prosthesis with a diameter of 32mm or more has the major advantage to increase the Range of Motion (ROM) and to reduce the risk of dislocation of the hip but, the larger the caput prosthesis the more adhesive wear can be expected. This and the relative failure of metal on PE gave the incentive to develop and take into clinical practise bearings with increased resilience to wear. Today, there exists a wide range of options with a substantially lower rate of volumetric wear compared to conventional PE. The biological and immunological in vivo response to wear particles is very complicated and only partially understood. It is clear that host response to wear particles and the corrosion products play a major role in osteolysis around the prosthesis. For metal-on-metal (MoM) bearings the volumetric wear is a magnitude less but the number of particle debris is massively increased. MoM also have the problem with possible teratogen effect and allergy or hypersensitivity side effects. Ceramic on ceramic (cer-cer) has the lowest wear rate of any artificial articulations, but it is still possible to detect biologically active debris particles. Cer-cer also has other challenges including fracture of prosthesis, squeaking hip, narrow margins for placing components and cost.
Polyethylene is a thermoplastic polymer consisting of long chains of the monomer ethylene (C2H4). The mechanical properties of PE depend on variables such as the extent and type of branching and the crystal structure etc.
To improve the wear resistance of the PE an increase in the cross-linking between the chains of polyethylene can be achieved by exposing it to high-energy irradiation. The irradiation also increases the unpaired free electrons (free radicals). Free radicals can react with oxygen and start a chain reaction causing an oxidative degradation of the polyethylene and consequently cause increased wear. 1st generation HXLPE sockets have reduced the mid term incidence of particle-induced osteolysis but retrieved failed first-generation HXLPE sockets have shown surface cracking and signs of in vivo oxidative degradation.
In order to enhance the resistance to mechanical fatigue and reduce oxidative potential 2nd generation HXLPE was developed. To reduce the oxidative potential the polyethylene can be remelted or annealed. Remelting aggravates the mechanical properties of the polyethylene and after annealing there are still remaining free radicals capable of oxidation in vivo. By binding to unpaired free electrons Vitamin E is a scavenger of free radicals. Vitamin E is hydrophobic and can thereby be infused into polyethylene. 3rd generation HXLPE is manufactured below the melting temperature to maintain its mechanical properties and contains Vitamin E to stabilize free radicals. Uncemented Acetabular HXLPE sockets have been shown to have substantially reduced volumetric wear and excellent clinical mid-term results with this type of PE. In Scandinavia the majority of sockets are cemented. The different principles of biological or mechanical stability affects the properties of the socket typically different E-module and the surrounding interface between implant and bone. Conventional PE cemented cups have performed better with less aseptic loosening than uncemented cups. However, as the mechanical properties are changed in highly cross-linked Polyethylene cups, it is not clear whether the higher elasticity of the bone-cement-polyethylene compound might lead to fractures of the more brittle polyethylene. It is therefore not possible to extrapolate clinical results and wear rates from uncemented cups to cemented ones.
Placement of the cup is a crucial parameter for wear and cup survival. Malchau et al. has shown that even high volume surgeons achieve suboptimal placement in 40% of cases. This may depend on patient positioning perioperative, surgical instruments or technique. It is not known whether the surgeon's subjective operative technique directly corresponds to the postoperative evaluation of the cups position. However, adequate cup positioning is crucial in the evaluation of wear. CT is the best method to judge cup position postoperatively and detect osteolysis in the long time perspective.
To the investigators knowledge no randomized controlled study of cemented 3rd generation HXLPE cups utilizing RSA has been conducted.
Hypothesis There is a mid term in vivo reduction of volumetric polyethylene wear with cemented acetabular socket 3rd generation E1™ HXLPE compared with 2nd generation HXLPE.
Material: 70 eligible patients will be included following written informed consent. The participants will be randomized by the envelope method to either E1™ or Marathon™ cemented acetabular socket. The surgery will be performed at the hospitals in Vestre Viken HF and Oslo University hospital HF, Ullevål ortopeden.
Implant The investigators will use two different cemented all PE acetabular sockets;
1. MarathonTM is a 1st generation HXLPE. The polyethylene is cross-linked with 5 Mrad that corresponds to a semi cross-linked PE.
2. The E1™ cemented is an all PE Vitamin E stabilized 3rd generation highly crosslinked UHMWPE. In vitro tests have shown a 99 % decreased volumetric wear rate comparing E1™ with ArComXL™ HXLPE, (highly crosslinked polyethylene) under high contact stress and a 95% reduction in wear rate comparing E1™ with ArCom™ under high contact area stress. Wear particle morphology of E1™ is similar to that of the ArCom™ material.
Collared Corail™ (De Puy, Warsaw, Indiana, USA) uncemented femoral prosthesis is a titanium tapered implant fully coated with 150 micron hydroxyapatite with over 95% survival after 15 years. The caput prosthesis used is the Cobalt Chrome 32 mm Articul/EZE™ (De Puy, Warsaw, Indiana, USA) Refobacin ™ (Biomet Europe, Berlin, Germany) Bone Cement R is a high viscosity, x-ray positive bone cement. A sachet of 40 g Refobacin® Bone Cement R contains 0.5 g gentamicin.
Surgical technique The patient is operated in the position after surgeon's preference and under spinal anaesthesia. Accordingly the approach is after surgeon's preference. When posterolateral approach is chosen a repair of the capsule and the external rotators should be performed. Peroperatively a total of 6 1,0mm tantalum beads are implanted in the perimeter of the socket and 7 beads in the acetabulum. The acetabular socket is positioned as close to 45◦ abduction and 30◦ anteversion as possible.
The surgeon will postoperative directly grade cup position subjectively as anteverted, neutral, retroverted, proximalized, distalized.
Postoperative training Postoperatively the patient is mobilized with full weight bearing from day one.
Radiological analyses Conventional x-ray of pelvis, anterioposterior and lateral projections of hip preoperatively, postoperatively and at 24 (60, 120) months RSA (Radiostereometric analysis) postoperatively, 3, 12, 24 (60, 120) months, the RSA will be analysed at Ullevål University Hospital
Clinical Control Harris Hip Score, EQ-5D and WOMAC will be filled out preoperatively and at 2, 5 and 10 years.
Analysis of data RSA analysis will be performed at the Centre of Implant and Radiostereometric Research Oslo (CIRRO).
The study analysis is conducted under the guidance of CIRRO.
Storage of data Data will be collected and stored at the server for research at Oslo University Hospital. All data is stored anonymously. Each patient receives a study ID. The randomisation key and identity is stored separately.
Statistics Penetration of more than 0,1 mm annually in polyethylene articulations indicates a wear rate that will lead to future osteolysis1.
Scientific value Firstly, if recently developed manufacturing techniques of polyethylene can be shown to decrease the wear rate in vivo, and otherwise have a good clinical and radiological outcome, we have the reason to believe we have the possibility of significantly reducing the revision rate after THA.
Secondly, new implants should thoroughly be investigated and documented before widespread use. This could save many patients from possible disastrous failures as the past has taught us (Boneloc, Carbon compressed Poly).
Safety for the patient. The investigators will follow the normal routines for THA pre, per and postoperatively. Standardized routines in regards to infection and thrombosis prophylaxis following the recommendations from the Norwegian national board of orthopaedics will be followed. Implantation of Tantalum beads has been shown to have negligible side effects.
The E1TM and Marathon PE is clinically tested in uncemented THA, the other components of the prosthesis has more than 10 years clinical and RSA documentation.
Biomet will cover expenses including:
Extra cost of purchasing and storing prosthesis compared with standard prosthesis. Biomet or Stryker has no copy right or any other form of ownership to the result of this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Total Hip Arthroplasty (THA)
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized controlled trial (RCT). Randomized to either E1 semented cup or Marathon semented cup in total hip arthroplasty (THA).
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
E1 Vitamin E infused HXLPE
E1 Vitamin E infused highly cross-linked polyethylene (HXLPE)
Group Type
ACTIVE_COMPARATOR
Prosthesis component (acetabular cup) E1 cup
Intervention Type
DEVICE
Semented acetabuar cup With E1 cup
Marathon HXLPE
Marathon highly cross-linked polyethylene (HXLPE)
Group Type
ACTIVE_COMPARATOR
Prosthesis component (acetabular cup) Marathon cup
Intervention Type
DEVICE
Semented acetabuar cup With Marathon cup
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prosthesis component (acetabular cup) E1 cup
Semented acetabuar cup With E1 cup
Intervention Type
DEVICE
Prosthesis component (acetabular cup) Marathon cup
Semented acetabuar cup With Marathon cup
Intervention Type
DEVICE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
E1 cup
Marathon cup
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients under the age of 75 with primary or secondary arthrosis scheduled for total hip arthroplasty.
Exclusion Criteria
* a major anatomical deviation, immunosuppressive medication or a significant systemic disease.
Maximum Eligible Age
74 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oslo
OTHER
Sponsor Role
collaborator
Oslo University Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peder Svenkerud Thoen
MD, Consultant Orthopedic Surgery
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephan M Röhrl, PhD, MD
Role: STUDY_CHAIR
Division of Orthopedic Surgery, Oslo University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Division of Orthopedic Surgery, Oslo Univsersity Hospital
Oslo, , Norway
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Norway
References
Explore related publications, articles, or registry entries linked to this study.
Digas G, Karrholm J, Thanner J, Malchau H, Herberts P. The Otto Aufranc Award. Highly cross-linked polyethylene in total hip arthroplasty: randomized evaluation of penetration rate in cemented and uncemented sockets using radiostereometric analysis. Clin Orthop Relat Res. 2004 Dec;(429):6-16.
Reference Type
BACKGROUND
Kjærsgaard-Andersen 2010 Orthopaedics today
Reference Type
BACKGROUND
The Norwegian Arthroplasty Register, 2009
Reference Type
BACKGROUND
Garcia-Cimbrelo E, Munuera L. Early and late loosening of the acetabular cup after low-friction arthroplasty. J Bone Joint Surg Am. 1992 Sep;74(8):1119-29.
Reference Type
BACKGROUND
Barrack RL, Folgueras A, Munn B, Tvetden D, Sharkey P. Pelvic lysis and polyethylene wear at 5-8 years in an uncemented total hip. Clin Orthop Relat Res. 1997 Feb;(335):211-7.
Reference Type
BACKGROUND
Tarasevicius S, Robertsson O, Kesteris U, Kalesinskas RJ, Wingstrand H. Effect of femoral head size on polyethylene wear and synovitis after total hip arthroplasty: a sonographic and radiographic study of 39 patients. Acta Orthop. 2008 Aug;79(4):489-93. doi: 10.1080/17453670710015472.
Reference Type
BACKGROUND
Harris WH, Muratoglu OK. A review of current cross-linked polyethylenes used in total joint arthroplasty. Clin Orthop Relat Res. 2005 Jan;(430):46-52. doi: 10.1097/01.blo.0000152603.58384.e9.
Reference Type
BACKGROUND
Jacobs JJ, Roebuck KA, Archibeck M, Hallab NJ, Glant TT. Osteolysis: basic science. Clin Orthop Relat Res. 2001 Dec;(393):71-7. doi: 10.1097/00003086-200112000-00008.
Reference Type
BACKGROUND
Doorn PF, Campbell PA, Worrall J, Benya PD, McKellop HA, Amstutz HC. Metal wear particle characterization from metal on metal total hip replacements: transmission electron microscopy study of periprosthetic tissues and isolated particles. J Biomed Mater Res. 1998 Oct;42(1):103-11. doi: 10.1002/(sici)1097-4636(199810)42:13.0.co;2-m.
Reference Type
BACKGROUND
Campbell DG, Field JR, Callary SA. Second-generation highly cross-linked X3 polyethylene wear: a preliminary radiostereometric analysis study. Clin Orthop Relat Res. 2010 Oct;468(10):2704-9. doi: 10.1007/s11999-010-1259-y. Epub 2010 Feb 12.
Reference Type
BACKGROUND
Ries MD, Pruitt L. Effect of cross-linking on the microstructure and mechanical properties of ultra-high molecular weight polyethylene. Clin Orthop Relat Res. 2005 Nov;440:149-56. doi: 10.1097/01.blo.0000185310.59202.e5.
Reference Type
BACKGROUND
Bitsch RG, Loidolt T, Heisel C, Ball S, Schmalzried TP. Reduction of osteolysis with use of Marathon cross-linked polyethylene. A concise follow-up, at a minimum of five years, of a previous report. J Bone Joint Surg Am. 2008 Jul;90(7):1487-91. doi: 10.2106/JBJS.F.00991.
Reference Type
BACKGROUND
Rohrl S, Nivbrant B, Mingguo L, Hewitt B. In vivo wear and migration of highly cross-linked polyethylene cups a radiostereometry analysis study. J Arthroplasty. 2005 Jun;20(4):409-13. doi: 10.1016/j.arth.2004.09.040.
Reference Type
BACKGROUND
Rohrl SM, Li MG, Nilsson KG, Nivbrant B. Very low wear of non-remelted highly cross-linked polyethylene cups: an RSA study lasting up to 6 years. Acta Orthop. 2007 Dec;78(6):739-45. doi: 10.1080/17453670710014509.
Reference Type
BACKGROUND
Malchau H. Revision total hip arthroplasty. Failure mechanisms and outcomes. Orthopedics. 1996 Sep;19(9):769-70. doi: 10.3928/0147-7447-19960901-17. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010/2621a
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Polyethylene Wear Particle Analysis of THA
NCT06432543
RECRUITING
A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement
NCT00208442
COMPLETED
PHASE4
Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
NCT01121146
COMPLETED
NA
Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary THA Using RSA
NCT00551967
UNKNOWN
NA
Radiographic Changes and Clinical Implications of Implantation of Shortened Uncemented Femoral Stems in THA
NCT05666284
UNKNOWN
Evaluation of Cemented and Cementless Fixation of Dual-mobility Hip Prosthesis in Elderly Patients With Osteoarthritis
NCT02404727
COMPLETED
NA
"How do Contrast Medias in Bone Cement Affect DXA Measurements After THR"
NCT00473421
UNKNOWN
PHASE1/PHASE2
Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty
NCT03692364
UNKNOWN
NA
Marathon and Enduron Polyethylene at Long-Term Follow-up
NCT02508428
COMPLETED
NA
Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups
NCT05773261
ACTIVE_NOT_RECRUITING
NA
Analysis of Crosslinked and Conventional Polyethylene Explants
NCT01484002
UNKNOWN
Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture
NCT04034043
COMPLETED
A Randomized RSA Study Comparing HXLPE to Conventional Polyethylene in Cemented Total Hip Arthroplasty
NCT04322799
COMPLETED
NA
Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty
NCT01319227
UNKNOWN
NA
Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
NCT04322916
UNKNOWN
Cemented vs. Cementless TKA
NCT04597684
TERMINATED
NA
Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study
NCT02355652
WITHDRAWN
PHASE4
Exception Cementless Hip Stem
NCT04349046
ACTIVE_NOT_RECRUITING
Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings
NCT01806766
COMPLETED
PHASE4
Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem
NCT01422564
TERMINATED
PHASE4
HXLPE Vs CPE Cups Under 50 Years
NCT06706193
COMPLETED
PHASE4
A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System
NCT06564636
ENROLLING_BY_INVITATION
Changes of Bone Mineral Density in Total Hip Arthroplasty
NCT04962854
COMPLETED
A Comparative Study of Stem and Cup Fixation and Polyethylene Wear
NCT04064723
ACTIVE_NOT_RECRUITING
NA
RSA-Study of Cemented Hip Prostheses With Five Different Articulations
NCT00698672
UNKNOWN
NA