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

Phase 3

Terminated

• Conditions: Post-traumatic Arthritis; Congenital Hip Dysplasia; Osteoarthritis; Avascular Necrosis; Slipped Capital Femoral Epiphysis; Collagen Disorder; Nonunion of Femoral Fractures; Traumatic Femoral Fractures
• Interventions: Device: Ultima LX Collarless Stem - Non-Polished/Blasted Finished; Device: Ultima LX Collared Stem - Non-Polished/Blasted Finished; Device: Ultima LX Collared Stem - Polished Finished; Device: Ultima LX Collarless Stem - Polished finished

• Registration Number: NCT00208351
• Lead Sponsor: DePuy International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-05
• Primary Completion: 2004-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2015-03
• Status Verified: 2016-03
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 164

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished	Ultima LX Collarless Stem - Non-Polished/Blasted Finished	A collarless 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 - Non-Polished/Blasted Finished	A collared non-polished blasted finished cementless femoral component for use in total hip replacement.
2) Ultima LX Collared Stem - Polished Finished	Ultima LX Collared Stem - Polished Finished	A collared polished finished cementless femoral component for use in total hip replacement.
4) Ultima LX Collarless Stem - Polished Finished	Ultima LX Collarless Stem - Polished finished	A collarless polished finished cementless femoral component for use in total hip replacement.

Primary Outcome Measures

Name	Time	Method
Stem movement measured radiographically at 2 years	2yrs post-surgery	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

Name	Time	Method
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	The following outcome measures were used; VAS Pain score, SF36 Patient reported outcome, Satisfaction, Limb Length physical examination, and stem movement measured radiographically.

Trial Locations

Locations (1)

Epsom General Hospital; 🇬🇧 Surrey, United Kingdom