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

Total Hip Arthroplasty Clinical Trial

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918540
• Other study ID #: Centralizer study
• Status: Completed
• Phase: N/A
• First received: July 4, 2013
• Last updated: November 25, 2014
• Start date: February 2003
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Procedure:
• Hollow Centralizer
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
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

Device:
• MS-30 femoral stem
This is the stem used in the study.

Locations

Country	Name	City	State
Sweden	Department of Orthopedics, Skane University Hospital, Lund University	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiostereometric Analysis (RSA)	This will measure the change in stem migration over time and be indicative of long term result.	The first postoperative day, 6 months, 1, 2, 5 and 10 years	No
Secondary	x-ray	On standard x-rays the progress of radiolucent lines or other signs of loosening will be measured	The first postoperative day, 6 months, 1, 2, 5 and 10 years	No
Secondary	Hip specific questionnaire	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	Preoperatively, 1, 2, 5 and 10 years	No
Secondary	General health questionnaire	EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome	Preoperatively, 1, 2, 5 and 10 years	No