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

Sponsor

Region Skane (Other)

Overall Status

Completed

CT.gov ID

NCT01918540

Collaborator

(none)

Enrollment

Location

Arms

141

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	Procedure: Hollow Centralizer Procedure: Solid Centralizer Device: MS-30 femoral stem	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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).

Study Start Date :

Feb 1, 2003

Actual Primary Completion Date :

Feb 1, 2004

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hollow Centralizer The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer.	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 Device: MS-30 femoral stem This is the stem used in the study.
Active Comparator: Solid Centralizer The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer.	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: Hollow Centralizer

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

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

Device: MS-30 femoral stem

This is the stem used in the study.

Active Comparator: Solid Centralizer

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

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Radiostereometric Analysis (RSA) [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 Outcome Measures

x-ray [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
Hip specific questionnaire [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
General health questionnaire [Preoperatively, 1, 2, 5 and 10 years]
EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Orthopedics, Skane University Hospital, Lund University	Lund	Skåne	Sweden	221 85

Sponsors and Collaborators

Region Skane

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Region Skane

ClinicalTrials.gov Identifier:

NCT01918540

Other Study ID Numbers:

Centralizer study

First Posted:

Aug 7, 2013

Last Update Posted:

Nov 26, 2014

Last Verified:

Nov 1, 2014

Keywords provided by Region Skane

Radiostereometry

Total Hip Arthroplasty

Stem design

Study Results

No Results Posted as of Nov 26, 2014