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

NCT ID: NCT01118247

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2023-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pure Ti

Cup and stem partly coated with pure titanium

Group Type: EXPERIMENTAL

Uncemented primary total hip arthroplasty

Intervention Type: PROCEDURE

Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.

pure Ti and HA

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

Group Type: ACTIVE_COMPARATOR

Uncemented primary total hip arthroplasty

Intervention Type: PROCEDURE

Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.

Interventions

Uncemented primary total hip arthroplasty

Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.

Intervention Type: PROCEDURE

Other Intervention Names

Cup: Igloo, Biotechni, Fr; Stem: Filler, Biotechni, Fr; Head, liner: Biotechni, Fr, Morgan, GB

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olav Reikerås, MD, Prof

Role: STUDY_DIRECTOR

Department of Orthopaedics, Rikshospitalet University Clinic, University of Oslo, N-0027 Oslo, Norway.

Arvid Småbrekke, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway

Locations

Ortopaedic Department, University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

Other Identifiers

200602701-8/IAY/400

Identifier Type: OTHER

Identifier Source: secondary_id

P-REK NORD 44/206

Identifier Type: -

Identifier Source: org_study_id