A Randomised Multi-centre Study to Compare the Short-term Outcomes of Minimally Invasive and Conventional Surgery in Primary Total Hip Replacement

This study has been terminated.
(Combination of departure of Investigator from one site and slow recruitment rate)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00208416
First received: September 13, 2005
Last updated: September 8, 2014
Last verified: July 2014

September 13, 2005
September 8, 2014
October 2005
December 2007   (final data collection date for primary outcome measure)
  • Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches [ Time Frame: First post-operative day ] [ Designated as safety issue: No ]
  • Level of assistance required to perform 3 functional tasks (supine to sit, sit to stand and bed to chair transfer)on the second post-operative day [ Time Frame: Second post-operative day ] [ Designated as safety issue: No ]
  • Time taken (in seconds) for subjects to walk 10 metres on the second post-operative day. [ Time Frame: Second post-operative day ] [ Designated as safety issue: No ]
  • Amount of time (in seconds) for which subjects are able to stand on the operative leg on the second post-operative day. [ Time Frame: Second post-operative day ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00208416 on ClinicalTrials.gov Archive Site
  • Haematological parameters assessed over a 56 hours post op [ Time Frame: 56 hours post-operatively ] [ Designated as safety issue: No ]
  • Pain levels and wound condition [ Time Frame: Until discharge ] [ Designated as safety issue: No ]
  • Trendelenberg sign [ Time Frame: Until discharge ] [ Designated as safety issue: No ]
  • Day of discharge [ Time Frame: Until discharge ] [ Designated as safety issue: No ]
  • Activity levels over specified distances [ Time Frame: Until discharge ] [ Designated as safety issue: No ]
  • Harris Hip score [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • Oxford Hip score [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • Radiological analysis [ Time Frame: 6weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Randomised Multi-centre Study to Compare the Short-term Outcomes of Minimally Invasive and Conventional Surgery in Primary Total Hip Replacement
Randomised, Prospective, Post-Market Surveillance Study Comparing the Outcomes of Minimally Invasive and Conventional Surgical Procedures in Subjects Requiring Primary Total Hip Arthroplasty for Osteoarthritis.

The purpose of this study is to compare the short-term outcomes of two surgical techniques, minimally invasive and conventional, when used in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to undergo surgery using the minimally invasive or conventional surgical technique and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments with a focus on short term rehabilitation.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Osteoarthritis(Primary)
  • Procedure: DePuy MI System
    A minimally invasive surgical technique used in total hip replacement.
  • Procedure: Conventional surgical technique
    A conventional surgical technique used in total hip replacement
  • Active Comparator: 1
    DePuy MI System
    Intervention: Procedure: DePuy MI System
  • Active Comparator: 2
    Conventional surgical technique
    Intervention: Procedure: Conventional surgical technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
61
April 2009
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

i) Male or female subjects, aged between 18 and 75 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects with a primary diagnosis of osteoarthritis.

v) Subjects considered suitable for a primary total hip arthroplasty and are considered suitable for a minimally invasive surgical procedure.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study, or extend their time to discharge beyond that required for their hip replacement surgery.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects with a Body Mass Index (BMI) > 30.

vii) Subjects with a malunion, arthrodesis or severe dysplasia with superior femoral head migration.

viii) Subjects requiring a simultaneous bilateral total hip arthroplasty.

ix) Subjects undergoing the second stage of a staged bilateral who are less than 9 months post-arthroplasty

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00208416
CT02/29
No
DePuy International
DePuy International
Not Provided
Not Provided
DePuy International
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP