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A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
DePuy International
ClinicalTrials.gov Identifier:
NCT00208351
First received: September 13, 2005
Last updated: September 1, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX hip stem in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the 4 designs of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Condition Intervention Phase
Osteoarthritis
Post-traumatic Arthritis
Collagen Disorder
Avascular Necrosis
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
 Device: Ultima LX Collared Stem - Blasted Finished
Device: Ultima LX Collared Stem - Polished Finished
Device: Ultima LX Collarless Stem - Blasted Finished
Device: Ultima LX Collarless Stem - Polished finished
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Evaluation to Compare a Polished and Non-polished Collared Stem and a Polished and Non Polished Collarless Stem in Primary Total Hip Replacement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Stem movement measured radiographically at 2 years [ Time Frame: 2yrs post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparisons of clinical assessment, satisfaction, physical examination, SF36 and radiographs at 5 years [ Time Frame: 5yrs post-surgery ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: May 1997
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1) Ultima LX Collared Stem - Blasted Finished
A collared blasted finished cementless femoral component for use in total hip replacement.
 Device: Ultima LX Collared Stem - Blasted Finished
A collared blasted finished cementless femoral component for use in total hip replacement.
Active Comparator: 2) 2) Ultima LX Collared Stem - Polished Finished
A collared polished finished cementless femoral component for use in total hip replacement.
 Device: Ultima LX Collared Stem - Polished Finished
A collared polished finished cementless femoral component for use in total hip replacement.
Active Comparator: 3) 3) Ultima LX Collarless Stem - Blasted Finished
A collarless blasted finished cementless femoral component for use in total hip replacement.
 Device: Ultima LX Collarless Stem - Blasted Finished
A collarless blasted finished cementless femoral component for use in total hip replacement.
Active Comparator: 4) 4) Ultima LX Collarless Stem - Polished Finished
A collarless polished finished cementless femoral component for use in total hip replacement.
 Device: Ultima LX Collarless Stem - Polished finished
A collarless polished finished cementless femoral component for use in total hip replacement.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Current indications for primary total hip arthroplasty utilising a cemented femoral component. These include pain, deformity and loss of function which are not responsive to medical treatment

Exclusion Criteria:

i) Revision Total Hip Arthroplasty ii) Rheumatoid arthritis iii) Age greater than 80 years at time of surgery iv) Age less than 60 years at time of surgery v) Previous hip joint sepsis vi) Obesity vii) Patient likely to remain housebound once rehabilitation is complete

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208351

Locations
United Kingdom
Epsom General Hospital
Surrey, United Kingdom, KT18 7EG
Sponsors and Collaborators
DePuy International
  More Information

No publications provided

Responsible Party: Roy Harvey, DePuy International Ltd
ClinicalTrials.gov Identifier: NCT00208351     History of Changes
Other Study ID Numbers: CT01/95
Study First Received: September 13, 2005
Last Updated: September 1, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by DePuy International:
Hip
Cemented

Additional relevant MeSH terms:
Arthritis
Collagen Diseases
Femoral Fractures
Fractures, Bone
Hip Dislocation, Congenital
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
 Musculoskeletal Diseases
Connective Tissue Diseases
Wounds and Injuries
Leg Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Pathologic Processes
Bone Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013