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

NCT00208416 | Terminated Phase 4

• 1 other identifier: CT02/29
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis(Primary)

Keywords

Hip; Surgical Technique

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

DePuy MI System

Procedure: DePuy MI System

2

ACTIVE COMPARATOR

Conventional surgical technique

Procedure: Conventional surgical technique

Interventions

DePuy MI System PROCEDURE

A minimally invasive surgical technique used in total hip replacement.

1

Conventional surgical technique PROCEDURE

A conventional surgical technique used in total hip replacement

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• DePuy International: lead

Study Sites (2)

Rotherham General Hospitals NHS Trust

Rotherham, South Yorkshire, United Kingdom

Location

Warwick Hospital NHS Trust

Warwick, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: November 1, 2014
• Last Updated: May 11, 2016

Record last verified: 2016-03

Locations

GB (2)