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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00208351
Other study ID # CT01/95
Secondary ID
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


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
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