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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis(Primary)
• Intervention / Treatment: Procedure: DePuy MI System; Procedure: Conventional surgical technique

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Warwick, United Kingdom
    • Warwick Hospital NHS Trust
  • South Yorkshire
    • Rotherham, South Yorkshire, United Kingdom
      • Rotherham General Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches	First post-operative day
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	Second post-operative day
Time taken (in seconds) for subjects to walk 10 metres on the second post-operative day.	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.	Second post-operative day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Hip; Surgical Technique
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CT02/29