Advertisement

Topics

Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation

2014-07-23 21:09:18 | BioPortfolio

Summary

Both HA coated and certain uncoated stems have good results in general. On the cup side the results are more variable, either with or without HA. HA may delaminate from the prosthesis, damage the articulation, witch may lead to osteolysis and aseptic loosening.

The investigators are investigating whether a well working uncemented hip prosthesis design with HA coating, will perform without HA in the long run, when the investigators use pure Ti macrostructure and alumina on alumina articulation.

Hypothesis: The bone ingrowth will be equal when the surface has almost equal roughness in Ti and HA version. This means that HA on Ti is not necessary with a well functioning prosthesis design.

0-hypothesis:The two prosthesis perform equal in survival, clinically (HHS),radiographic and in patient satisfaction at 2, 5, 10, 15 and 20 years.

Description

Investigate survival of the implants and possible biological consequences. Clinical outcome with Harris Hip Score. Radiographic outcome with a modified protocol after JRC, JBJS 1990. Patient satisfaction with the hip prosthesis (five categories).

Grit blasted TiAL6V4 + pure Ti versus grit blasted TiAL6V4 + pure Ti +HA, with almost the same roughness. Screw cup, double tapered stem, partly double coated cup, proximally double coated stem.

Prospective RCT. Multicenter ( Three hospitals). Selected surgeons. Non-inferiority-design.

At present 343 hips (263 patients, 80 bilateral) are randomized into the study. 210 hips have completed follow ups at an average of 1,98 years, and 37 hips have completed follow ups at an average of 4,97 years.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Survival of the Implants With Revision as Endpoint

Intervention

Uncemented primary total hip arthroplasty

Location

Ortopaedic Department, University Hospital of North Norway
Tromsø
Norway
9016

Status

Recruiting

Source

University Hospital of North Norway

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:18-0400

Clinical Trials [1975 Associated Clinical Trials listed on BioPortfolio]

ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibia...

ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibia...

Evaluation of Stability of Two Uncemented Hip Implants Used for Total Hip Arthroplasty

The purpose of this study is to measure quantitatively the implant stability and implant related remodeling of the periprosthetic femoral bone of the new uncemented Echo® Bi-Metric® Full...

Tranexamic Acid in Revision Total Joint Arthroplasty

To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA) [single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral repeate...

Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty

Long term follow-up is needed to determine whether current Mobile Bearing revision Total Knee Arthroplasty (TKA) designs will improve implant longevity. The potential advantages of mobile...

PubMed Articles [16900 Associated PubMed Articles listed on BioPortfolio]

The minimalinvasive direct anterior approach in aseptic cup revision hip arthroplasty: a mid-term follow-up.

The minimally invasive direct anterior approach (DAA) is an established approach for primary total hip arthroplasty (THA). The complication rates in hip revision arthroplasty are much higher in compar...

Periprosthetic Bone Mineral Density Around Uncemented Titanium Stems in the Second and Third Decade After Total Hip Arthroplasty: A DXA Study After 12, 17 and 21 Years.

Implant failure and periprosthetic fractures because of periprosthetic bone loss are a major concern in total hip arthroplasty (THA). Hardly any clinical data exist on the long-term evolution of bone ...

Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision.

Background and purpose - In the Netherlands about 40% of hip fractures are treated with a hemiarthroplasty (HA) or a total hip arthroplasty (THA). Although these procedures are claimed to have fewer c...

Mid-Term Survival of Total Knee Arthroplasty in Patients with Posttraumatic Osteoarthritis.

PURPOSE OF THE STUDY There is limited evidence on survival and complication rates in patients after total knee arthroplasty for posttraumatic osteoarthritis. The failure mechanisms leading to revision...

Antibiotic-laden Bone Cement in Primary and Revision Hip and Knee Arthroplasty.

Antibiotic-laden bone cement (ALBC) has a number of different uses in primary and revision total joint arthroplasty. However, considerable controversy remains regarding how and when it is best used. T...

Medical and Biotech [MESH] Definitions

Partial or total replacement of a joint.

Partial or total replacement of one or more FINGERS, or a FINGER JOINT.

Multi-channel hearing devices typically used for patients who have tumors on the COCHLEAR NERVE and are unable to benefit from COCHLEAR IMPLANTS after tumor surgery that severs the cochlear nerve. The device electrically stimulates the nerves of cochlea nucleus in the BRAIN STEM rather than the inner ear as in cochlear implants.

Implants constructed of materials designed to be absorbed by the body without producing an immune response. They are usually composed of plastics and are frequently used in orthopedics and orthodontics.

The survival of a graft in a host, the factors responsible for the survival and the changes occurring within the graft during growth in the host.

More From BioPortfolio on "Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Osteoporosis
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...

Biological Therapy
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...


Searches Linking to this Trial