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Completed

NCT Number: NCT01918540

Importance of Hollow or Solid Centralizer for Polished, Collarless and Tapered Stems in Total Hip Arthroplasty

The study aims at comparing the effect of hollow or solid centralizer designs on the long time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In a prospective, controlled and randomized study comprising two groups of 30 patients/hips each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In completion general health questionnaires as well as hip specific scoring instruments will be used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the different centralizers will result in different migration patterns of the stems, which might affect the risk for late aseptic loosening.

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Key information

Conditions

Total Hip Arthroplasty

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopedics, Skane University Hospital, Lund University

Lund, Skåne County, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary osteoarthritis of the hip necessitating primary hip replacement
  • Charnley classification group A and B
  • Age 60 - 85 years old at the inclusion time of the study.

Exclusion criteria

  • Secondary osteoarthritis
  • Rheumatoid arthritis
  • Malignant disease
  • Severe osteoporosis
  • Earlier fracture or operation in the hip to be operated on
  • Peroperative fracture
  • Ongoing corticosteroid (oral) or immunosuppressive medication
  • Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.

Treatment and study plan

Hollow Centralizer

Procedure

The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer

Solid Centralizer

Procedure

The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer

MS-30 femoral stem

Device

This is the stem used in the study.

Primary outcomes

  1. Radiostereometric Analysis (RSA)

    Time frame: The first postoperative day, 6 months, 1, 2, 5 and 10 years

    This will measure the change in stem migration over time and be indicative of long term result.

Secondary outcomes

  1. x-ray

    Time frame: The first postoperative day, 6 months, 1, 2, 5 and 10 years

    On standard x-rays the progress of radiolucent lines or other signs of loosening will be measured

  2. Hip specific questionnaire

    Time frame: Preoperatively, 1, 2, 5 and 10 years

    Hip disability and Osteoarthritis Score (HOOS) - this is a hip specific questionnaire that will measure how the operation has affected the patients hip function and pain situation

  3. General health questionnaire

    Time frame: Preoperatively, 1, 2, 5 and 10 years

    EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Comparing Hollow and Solid Centralizer Designs When Using a Polished, Collarless, Tapered Hip Prosthesis Stem (MS30). A Prospective, Randomized, Multicenter Study Evaluated by RadioStereometric Analysis (RSA).

Important dates

Study start
2003
Primary completion
2004
Study completion
2014
First posted
Aug 7, 2013
Registry last updated
Nov 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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