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

NCT01918540 | Completed

• 1 other identifier: Centralizer study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Keywords

Radiostereometry; Total Hip Arthroplasty; Stem design

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• x-ray

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

• Hip specific questionnaire

  Preoperatively, 1, 2, 5 and 10 years

• General health questionnaire

  Preoperatively, 1, 2, 5 and 10 years

Study Arms (2)

Hollow Centralizer

ACTIVE COMPARATOR

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; Device: MS-30 femoral stem

Solid Centralizer

ACTIVE COMPARATOR

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; Device: MS-30 femoral stem

Interventions

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

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

Solid Centralizer

MS-30 femoral stem DEVICE

This is the stem used in the study.

Hollow Centralizer; Solid Centralizer

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary osteoarthritis of the hip necessitating primary hip replacement
• Charnley classification group A and B

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Orthopedics, Skane University Hospital, Lund University

Lund, Skåne County, 221 85, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: August 7, 2013
• Study Start: February 1, 2003
• Primary Completion: February 1, 2004
• Study Completion: November 1, 2014
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

SE (1)