Clinical trial NCT00208416: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis(Primary)
Keywords: Hip
Surgical Technique
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches
timeFrame: First post-operative day
measure: 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
timeFrame: Second post-operative day
measure: Time taken (in seconds) for subjects to walk 10 metres on the second post-operative day.
timeFrame: Second post-operative day
measure: Amount of time (in seconds) for which subjects are able to stand on the operative leg on the second post-operative day.
timeFrame: Second post-operative day
Secondary outcomes:
measure: Haematological parameters assessed over a 56 hours post op
timeFrame: 56 hours post-operatively
measure: Pain levels and wound condition
timeFrame: Until discharge
measure: Trendelenberg sign
timeFrame: Until discharge and at 6 weeks
measure: Day of discharge
timeFrame: Until discharge
measure: Activity levels over specified distances
timeFrame: Until discharge
measure: Harris Hip score
timeFrame: 6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery
measure: Oxford Hip score
timeFrame: 6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery
measure: Radiological analysis
timeFrame: 6weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Other outcomes:
Locations:
city: Rotherham
country: United Kingdom
facility: Rotherham General Hospitals NHS Trust
state: South Yorkshire
city: Warwick
country: United Kingdom
facility: Warwick Hospital NHS Trust
Study officials:
References: