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 - Full Text View

Sponsored by:	DePuy International
Information provided by:	DePuy International
ClinicalTrials.gov Identifier:	NCT00208351

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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:

MedlinePlus related topics: Fractures Osteoarthritis Osteonecrosis

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
1) Ultima LX Collared Stem - Blasted Finished: Active Comparator 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.
2) 2) Ultima LX Collared Stem - Polished Finished: Active Comparator 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.
3) 3) Ultima LX Collarless Stem - Blasted Finished: Active Comparator 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.
4) 4) Ultima LX Collarless Stem - Polished Finished: Active Comparator 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

Investigators

Study Director:

Michael Borroff, B.Sc. M.Sc.

DePuy International Ltd.

More Information

No publications provided

Responsible Party:	DePuy International Ltd ( Mick Borroff )
Study ID Numbers:	CT01/95
Study First Received:	September 13, 2005
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00208351 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by DePuy International:

Hip
Cemented

Study placed in the following topic categories:

Osteonecrosis
Collagen Diseases
Hip Dislocation
Osteoarthritis
Dislocations
Joint Diseases
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Rheumatic Diseases
Bone Diseases

Musculoskeletal Abnormalities
Femoral Fractures
Necrosis
Musculoskeletal Diseases
Epiphyses, Slipped
Arthritis
Connective Tissue Diseases
Hip Dysplasia
Leg Injuries
Congenital Abnormalities
Hip Dislocation, Congenital

Additional relevant MeSH terms:

Collagen Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Rheumatic Diseases
Bone Diseases
Musculoskeletal Abnormalities

Femoral Fractures
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Epiphyses, Slipped
Arthritis
Connective Tissue Diseases
Leg Injuries
Congenital Abnormalities
Hip Dislocation, Congenital

ClinicalTrials.gov processed this record on August 30, 2009