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

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Avascular Necrosis; Post-traumatic Arthritis; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Collagen Disorder
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey, United Kingdom, KT18 7EG
    • Epsom General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The following outcome measures were used; VAS Pain score, SF36 Patient reported outcome, Satisfaction, Limb Length physical examination, and stem movement measured radiographically.	5yrs post-surgery

Collaborators and Investigators

• Sponsor: DePuy International

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 1997
• Primary Completion (ACTUAL): November 1, 2004
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (ESTIMATE): September 21, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Hip; Cemented
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Bone Diseases, Developmental; Osteochondrodysplasias; Epiphyses, Slipped; Femoral Fractures; Necrosis; Fractures, Bone; Rheumatic Diseases; Collagen Diseases; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses
• Other Study ID Numbers: CT01/95