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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01118247
First Posted: May 6, 2010
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital of North Norway
  Purpose

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.


Condition Intervention
Survival of the Implants With Revision as Endpoint Clinical Performance With HHS Patients Satisfaction With the Hip Implant Procedure: Uncemented primary total hip arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Survival with revision as endpoint. [ Time Frame: 5-20 years ]

Secondary Outcome Measures:
  • Clinical outcome with Harris Hip Score. [ Time Frame: 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.

  • 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.


Estimated Enrollment: 400
Study Start Date: April 2004
Estimated Study Completion Date: March 2023
Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pure Ti
Cup and stem partly coated with pure titanium
Procedure: Uncemented primary total hip arthroplasty
Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.
Other Names:
  • Cup: Igloo, Biotechni, Fr
  • Stem: Filler, Biotechni, Fr
  • Head, liner: Biotechni, Fr, Morgan, GB
Active Comparator: pure Ti and HA
Cup and stem partly coated with pure titanium, and fully coated with HA.
Procedure: Uncemented primary total hip arthroplasty
Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.
Other Names:
  • Cup: Igloo, Biotechni, Fr
  • Stem: Filler, Biotechni, Fr
  • Head, liner: Biotechni, Fr, Morgan, GB

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118247


Locations
Norway
Ortopaedic Department, University Hospital of North Norway
Tromsø, Norway, 9016
Sponsors and Collaborators
University Hospital of North Norway
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
  More Information

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01118247     History of Changes
Other Study ID Numbers: P-REK NORD 44/206
200602701-8/IAY/400 ( Other Identifier: North Norwegian Ettic Commitee )
First Submitted: April 30, 2010
First Posted: May 6, 2010
Last Update Posted: August 17, 2017
Last Verified: June 2015

Keywords provided by University Hospital of North Norway:
Uncemented THA
alumina-on-alumina
survival
HHS
Patient satisfaction