Overview

This trial is active, not recruiting.

Conditions survival of the implants with revision as endpoint, clinical performance with hhs, patients satisfaction with the hip implant
Treatment uncemented primary total hip arthroplasty
Sponsor University Hospital of North Norway
Start date April 2004
End date March 2023
Trial size 400 participants
Trial identifier NCT01118247, 200602701-8/IAY/400, P-REK NORD 44/206

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cup and stem partly coated with pure titanium
uncemented primary total hip arthroplasty Cup: Igloo, Biotechni, Fr
Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.
(Active Comparator)
Cup and stem partly coated with pure titanium, and fully coated with HA.
uncemented primary total hip arthroplasty Cup: Igloo, Biotechni, Fr
Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.

Primary Outcomes

Measure
Survival with revision as endpoint.
time frame: 5-20 years

Secondary Outcomes

Measure
Clinical outcome with Harris Hip Score.
time frame: 10-30 years
Radiographic outcome.
time frame: 10-30years
Patient satisfaction with the hip prosthesis.
time frame: 10-30 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation
Principal investigator Arvid Småbrekke, MD
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 2,01 years, and 288 hips have completed follow ups at an average of 5,14 years.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University Hospital of North Norway.