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

NCT00208351 | Terminated Phase 3

• 1 other identifier: CT01/95
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis; Post-traumatic Arthritis; Collagen Disorder; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Keywords

Hip; Cemented

Outcome Measures

Primary Outcomes (1)

• Stem movement measured radiographically at 2 years

  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.

  2yrs post-surgery

Secondary Outcomes (1)

• 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.

  5yrs post-surgery

Study Arms (4)

1) Ultima LX Collared Stem - Non-Polished/Blasted Finished

ACTIVE COMPARATOR

A collared non-polished blasted finished cementless femoral component for use in total hip replacement.

Device: Ultima LX Collared Stem - Non-Polished/Blasted Finished

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

3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished

ACTIVE COMPARATOR

A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.

Device: Ultima LX Collarless Stem - Non-Polished/Blasted Finished

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

Interventions

Ultima LX Collared Stem - Non-Polished/Blasted Finished DEVICE

A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.

1) Ultima LX Collared Stem - Non-Polished/Blasted Finished

Ultima LX Collared Stem - Polished Finished DEVICE

A collared polished finished cementless femoral component for use in total hip replacement.

2) Ultima LX Collared Stem - Polished Finished

Ultima LX Collarless Stem - Non-Polished/Blasted Finished DEVICE

A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.

3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished

Ultima LX Collarless Stem - Polished finished DEVICE

A collarless polished finished cementless femoral component for use in total hip replacement.

4) Ultima LX Collarless Stem - Polished Finished

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DePuy International: lead

Study Sites (1)

Epsom General Hospital

Surrey, KT18 7EG, United Kingdom

Location

Related Publications (1)

• Hutt J, Hazlerigg A, Aneel A, Epie G, Dabis H, Twyman R, Cobb A. The effect of a collar and surface finish on cemented femoral stems: a prospective randomised trial of four stem designs. Int Orthop. 2014 Jun;38(6):1131-7. doi: 10.1007/s00264-013-2256-z. Epub 2014 Jan 29.

  PMID: 24474088 RESULT

MeSH Terms

Conditions

Osteoarthritis; Collagen Diseases; Osteonecrosis; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 1997
• Primary Completion: November 1, 2004
• Study Completion: March 1, 2015
• Last Updated: May 11, 2016

Record last verified: 2016-03

Locations

GB (1)