Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty

NCT00722982 | Unknown

• 1 other identifier: C-stem AMT
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Migration of C-Stem AMT is equal to the well documented Exeter prosthesis In Norway it is annually performed approximately 600 primary and 100 revisions THA. Osteolysis around the prosthesis is one of the major difficulties while performing revision surgery. C-stem is a triple tapered cemented prosthesis designed to increase the stress and strain of proximal femur and thereby decreasing osteolysis. We are planning til include 70 patients and randomize to C-stem AMT or Exeter prosthesis. Both prosthesis will be combined with previously non documented "Marathon" acetabular prosthesis. The result will be followed clinically and with RSA and DXA. Soft endpoint after 2 years

Conditions

Coxarthrosis

Keywords

coxarthrosis; hip; RSA; DXA; C-stem AMT; Marathon

Outcome Measures

Primary Outcomes (1)

• Migration of femur- and acetabular prosthesis measured by RSA

  2008-2012

Secondary Outcomes (1)

• Periprosthetic osteolysis of proximal femur

  2008-2012

Study Arms (2)

1

2

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

70 patients admitted to orthopedic clinic Ringerike hospital for coxarthrosis are planned to be included in stydy. The all should agree in a written form to participate in study. They are randomized to be operated THA with Exeter- or C-stem AMT femur prostesis. Marathon acetabular prosthesis will be used for all patients included.

You may qualify if:

• coxarthrosis

You may not qualify if:

• age over 80
• major medial condition such as renal failure, chronic obstructive lung disease heart failure etc

Sponsors & Collaborators

• Ullevaal University Hospital: lead
• Ringerike hospital HF, Hønefoss Norway: collaborator
• Ortomedic AS, Lysaker Norway: collaborator
• Helse Sor-Ost: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0407, Norway

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lars Nordsletten, Professor

  Ullevaal University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 28, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2015
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

NO (1)