Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation
Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation
Both HA coated and certain uncoated femoral 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 569 hips (391 patients, 178 bilateral) are randomized into the study. Inclusion of patients into the study stopped in January 2013.
548 hips have completed follow ups at an average of 2 years, 301 hips have completed follow ups at an average of 5 years and 60 hips at 8-10 years.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tromsø, Norway, 9016
- Ortopaedic Department, University Hospital of North Norway
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary or secondary osteoarthrosis.
- Both gender, less than seventy years.
- Patients operated for FCF and patients with previous osteotomies are included.
Exclusion Criteria:
- Treatment with Prednisolon.
- Osteomyelitis.
- Serious infections illnesses.
- Cancer or metastasis.
- Rheumatoid arthritis.
- Osteonecrosis after use of alcohol or medicaments.
- Kidney illnesses.
- Metabolic bone diseases.
- Earlier hip arthrodesis.
- Allergic reactions on implants.
- Patients who do not cooperate on rehabilitation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: pure Ti
Cup and stem partly coated with pure titanium
|
Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.
Other Names:
|
|
ACTIVE_COMPARATOR: pure Ti and HA
Cup and stem partly coated with pure titanium, and fully coated with HA.
|
Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Survival with revision as endpoint.
Time Frame: 5-20 years
|
5-20 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical outcome with Harris Hip Score.
Time Frame: 10-30 years
|
10-30 years
|
|
|
Radiographic outcome.
Time Frame: 10-30years
|
The radiographic evaluation will be carried out postoperatively, 2, 5, 10, 15 and 20 years after the operations with the same protocol modified after Johnston et al, JBJS Am. 1990;72: page 166.
We judge and compare a.p pelvic x-rays calibrated on the computer.
|
10-30years
|
|
Patient satisfaction with the hip prosthesis.
Time Frame: 10-30 years
|
At the consultations we ask the patient if he/she is satisfied with the hip.
The patient may answer i 5 categories (dissatisfied, not satisfied, satisfied, very satisfied and very much satisfied).
We also have registrations on early and late complications, leg length discrepancy, Trendelenburg lurch etc.
|
10-30 years
|
Collaborators and Investigators
Investigators
- Study Director: Olav Reikerås, MD, Prof, Department of Orthopaedics, Rikshospitalet University Clinic, University of Oslo, N-0027 Oslo, Norway.
- Principal Investigator: Arvid Småbrekke, MD, University Hospital of North Norway
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P-REK NORD 44/206
- 200602701-8/IAY/400 (OTHER: North Norwegian Ettic Commitee)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.