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 has been terminated.
(The final assessments were conducted late and in a reduced format due to resource limitations at the site.)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00208351
First received: September 13, 2005
Last updated: May 9, 2016
Last verified: March 2016
  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 - Non-Polished/Blasted Finished
Device: Ultima LX Collared Stem - Polished Finished
Device: Ultima LX Collarless Stem - Non-Polished/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:


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 ]
    Stem movement was measured radiographically by comparing baseline stem position with the stem position 2 years after surgery. If migration was observed to be 5 or more mm, it was considered clinically significant migration.


Secondary Outcome Measures:
  • Comparisons of Visual Analog Pain (VAS), 36-Item Short Form Health Survey (SF-36), Satisfaction, Limb Length and stem movement measured radiographically at 5 years. [ Time Frame: 5yrs post-surgery ] [ Designated as safety issue: No ]
    The following outcome measures were used; VAS Pain score, SF36 Patient reported outcome, Satisfaction, Limb Length physical examination, and stem movement measured radiographically.


Enrollment: 164
Study Start Date: May 1997
Study Completion Date: March 2015
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1) Ultima LX Collared Stem - Non-Polished/Blasted Finished
A collared non-polished blasted finished cementless femoral component for use in total hip replacement.
Device: Ultima LX Collared Stem - Non-Polished/Blasted Finished
A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.
Active Comparator: 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) Ultima LX Collarless Stem - Non-Polished/Blasted Finished
A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.
Device: Ultima LX Collarless Stem - Non-Polished/Blasted Finished
A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.
Active Comparator: 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00208351     History of Changes
Other Study ID Numbers: CT01/95 
Study First Received: September 13, 2005
Last Updated: May 9, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by DePuy International:
Hip
Cemented

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

ClinicalTrials.gov processed this record on July 27, 2016