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

University Hospital of North Norway

Status: Unknown

Conditions: Patients Satisfaction With the Hip Implant; Clinical Performance With HHS; Survival of the Implants With Revision as Endpoint

Treatments: Procedure: Uncemented primary total hip arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01118247

200602701-8/IAY/400 (Other Identifier)

P-REK NORD 44/206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

pure Ti

Experimental group

Description:

Cup and stem partly coated with pure titanium

Treatment:

Procedure: Uncemented primary total hip arthroplasty

pure Ti and HA

Active Comparator group

Description:

Cup and stem partly coated with pure titanium, and fully coated with HA.

Treatment:

Procedure: Uncemented primary total hip arthroplasty