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

February 18, 2019 updated by: University Hospital of North Norway

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway, 9016
        • Ortopaedic Department, University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival with revision as endpoint.
Time Frame: 5-20 years
5-20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome with Harris Hip Score.
Time Frame: 10-30 years
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.
10-30years
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.
10-30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

April 30, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (ESTIMATE)

May 6, 2010

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P-REK NORD 44/206
  • 200602701-8/IAY/400 (OTHER: North Norwegian Ettic Commitee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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