Clinical trial NCT01118247: Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation
Official title: Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Survival of the Implants With Revision as Endpoint
Clinical Performance With HHS
Patients Satisfaction With the Hip Implant
Keywords: Uncemented THA
alumina-on-alumina
survival
HHS
Patient satisfaction
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival with revision as endpoint.
timeFrame: 5-20 years
Secondary outcomes:
measure: Clinical outcome with Harris Hip Score.
timeFrame: 10-30 years
measure: Radiographic outcome.
timeFrame: 10-30years
measure: Patient satisfaction with the hip prosthesis.
timeFrame: 10-30 years
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Ortopaedic Department, University Hospital of North Norway
Study officials:
affiliation: Department of Orthopaedics, Rikshospitalet University Clinic, University of Oslo, N-0027 Oslo, Norway.
name: Olav Reikerås, MD, Prof
role: STUDY_DIRECTOR
affiliation: University Hospital of North Norway
name: Arvid Småbrekke, MD
role: PRINCIPAL_INVESTIGATOR
References: