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:
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01118247
First received: April 30, 2010
Last updated: January 27, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Clinical outcome with Harris Hip Score. [ Time Frame: 10-30 years ] [ Designated as safety issue: No ]
  • Radiographic outcome. [ Time Frame: 10-30years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2015 (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 567 hips (395 patients, 172 bilateral) are randomized into the study. Inclusion of patients into the study stopped in January 2013.

469 hips have completed follow ups at an average of 2,00 years, and 236 hips have completed follow ups at an average of 5,16 years.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 30, 2010
Last Updated: January 27, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health

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

ClinicalTrials.gov processed this record on April 22, 2014