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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208416
Recruitment Status : Terminated (Combination of departure of Investigator from one site and slow recruitment rate)
First Posted : September 21, 2005
Last Update Posted : May 11, 2016
Information provided by (Responsible Party):
DePuy International

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis(Primary) Procedure: DePuy MI System Procedure: Conventional surgical technique Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
DePuy MI System
Procedure: DePuy MI System
A minimally invasive surgical technique used in total hip replacement.

Active Comparator: 2
Conventional surgical technique
Procedure: Conventional surgical technique
A conventional surgical technique used in total hip replacement

Primary Outcome Measures :
  1. Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches [ Time Frame: First post-operative day ]
  2. 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 ]
  3. Time taken (in seconds) for subjects to walk 10 metres on the second post-operative day. [ Time Frame: Second post-operative day ]
  4. 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 ]

Secondary Outcome Measures :
  1. Haematological parameters assessed over a 56 hours post op [ Time Frame: 56 hours post-operatively ]
  2. Pain levels and wound condition [ Time Frame: Until discharge ]
  3. Trendelenberg sign [ Time Frame: Until discharge and at 6 weeks ]
  4. Day of discharge [ Time Frame: Until discharge ]
  5. Activity levels over specified distances [ Time Frame: Until discharge ]
  6. Harris Hip score [ Time Frame: 6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery ]
  7. Oxford Hip score [ Time Frame: 6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery ]
  8. Radiological analysis [ Time Frame: 6weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208416

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United Kingdom
Rotherham General Hospitals NHS Trust
Rotherham, South Yorkshire, United Kingdom
Warwick Hospital NHS Trust
Warwick, United Kingdom
Sponsors and Collaborators
DePuy International

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Responsible Party: DePuy International Identifier: NCT00208416    
Other Study ID Numbers: CT02/29
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: March 2016
Keywords provided by DePuy International:
Surgical Technique
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases