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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

Primary Purpose

Osteoarthritis(Primary)

Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
DePuy MI System
Conventional surgical technique
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis(Primary) focused on measuring Hip, Surgical Technique

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rotherham General Hospitals NHS Trust
  • Warwick Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

DePuy MI System

Conventional surgical technique

Outcomes

Primary Outcome Measures

Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches
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 taken (in seconds) for subjects to walk 10 metres on the second post-operative day.
Amount of time (in seconds) for which subjects are able to stand on the operative leg on the second post-operative day.

Secondary Outcome Measures

Haematological parameters assessed over a 56 hours post op
Pain levels and wound condition
Trendelenberg sign
Day of discharge
Activity levels over specified distances
Harris Hip score
Oxford Hip score
Radiological analysis

Full Information

First Posted
September 13, 2005
Last Updated
May 9, 2016
Sponsor
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT00208416
Brief Title
A Randomised Multi-centre Study to Compare the Short-term Outcomes of Minimally Invasive and Conventional Surgery in Primary Total Hip Replacement
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Combination of departure of Investigator from one site and slow recruitment rate
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis(Primary)
Keywords
Hip, Surgical Technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
DePuy MI System
Arm Title
2
Arm Type
Active Comparator
Arm Description
Conventional surgical technique
Intervention Type
Procedure
Intervention Name(s)
DePuy MI System
Intervention Description
A minimally invasive surgical technique used in total hip replacement.
Intervention Type
Procedure
Intervention Name(s)
Conventional surgical technique
Intervention Description
A conventional surgical technique used in total hip replacement
Primary Outcome Measure Information:
Title
Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches
Time Frame
First post-operative day
Title
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
Title
Time taken (in seconds) for subjects to walk 10 metres on the second post-operative day.
Time Frame
Second post-operative day
Title
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 Measure Information:
Title
Haematological parameters assessed over a 56 hours post op
Time Frame
56 hours post-operatively
Title
Pain levels and wound condition
Time Frame
Until discharge
Title
Trendelenberg sign
Time Frame
Until discharge and at 6 weeks
Title
Day of discharge
Time Frame
Until discharge
Title
Activity levels over specified distances
Time Frame
Until discharge
Title
Harris Hip score
Time Frame
6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery
Title
Oxford Hip score
Time Frame
6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery
Title
Radiological analysis
Time Frame
6weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rotherham General Hospitals NHS Trust
City
Rotherham
State/Province
South Yorkshire
Country
United Kingdom
Facility Name
Warwick Hospital NHS Trust
City
Warwick
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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