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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00208351
• Other study ID #: CT01/95
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 9, 2016
• Start date: May 1997
• Est. completion date: March 2015

Study information

• Verified date: March 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 164
• Est. completion date: March 2015
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avascular Necrosis
• Collagen Diseases
• Collagen Disorder
• Congenital Hip Dysplasia
• Femoral Fractures
• Fractures, Bone
• Hip Dislocation, Congenital
• Nonunion of Femoral Fractures
• Osteoarthritis
• Post-traumatic Arthritis
• Slipped Capital Femoral Epiphyses
• Slipped Capital Femoral Epiphysis
• Traumatic Femoral Fractures

Intervention

Device:
• Ultima LX Collared Stem - Non-Polished/Blasted Finished
A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.
• Ultima LX Collared Stem - Polished Finished
A collared polished finished cementless femoral component for use in total hip replacement.
• Ultima LX Collarless Stem - Non-Polished/Blasted Finished
A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.
• Ultima LX Collarless Stem - Polished finished
A collarless polished finished cementless femoral component for use in total hip replacement.

Locations

Country	Name	City	State
United Kingdom	Epsom General Hospital	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

United Kingdom, 

References & 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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No