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

• Sponsor: DePuy International (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00208416
• Collaborator: (none)
• Enrollment: 58
• Locations: 2
• Arms: 2
• Duration (Months): 109
• Patients Per Site: 29
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis(Primary)	Procedure: DePuy MI System; Procedure: Conventional surgical technique	Phase 4

Study Design

• Study Type: Interventional
• 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: Oct 1, 2005
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches [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 [Second post-operative day]

3. Time taken (in seconds) for subjects to walk 10 metres on the second post-operative day. [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. [Second post-operative day]

Secondary Outcome Measures

1. Haematological parameters assessed over a 56 hours post op [56 hours post-operatively]

2. Pain levels and wound condition [Until discharge]

3. Trendelenberg sign [Until discharge and at 6 weeks]

4. Day of discharge [Until discharge]

5. Activity levels over specified distances [Until discharge]

6. Harris Hip score [6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery]

7. Oxford Hip score [6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery]

8. Radiological analysis [6weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female subjects, aged between 18 and 75 years inclusive.

2. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

3. 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.

4. Subjects with a primary diagnosis of osteoarthritis.

5. Subjects considered suitable for a primary total hip arthroplasty and are considered suitable for a minimally invasive surgical procedure.

Exclusion Criteria:

1. 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.

2. Women who are pregnant.

3. Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

4. Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

5. Subjects who are currently involved in any injury litigation claims.

6. Subjects with a Body Mass Index (BMI) > 30.

7. Subjects with a malunion, arthrodesis or severe dysplasia with superior femoral head migration.

8. Subjects requiring a simultaneous bilateral total hip arthroplasty.

9. Subjects undergoing the second stage of a staged bilateral who are less than 9 months post-arthroplasty

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rotherham General Hospitals NHS Trust	Rotherham	South Yorkshire	United Kingdom
2	Warwick Hospital NHS Trust	Warwick		United Kingdom

Sponsors and Collaborators

• DePuy International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DePuy International
• ClinicalTrials.gov Identifier: NCT00208416
• Other Study ID Numbers: CT02/29
• First Posted: Sep 21, 2005
• Last Update Posted: May 11, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by DePuy International: Hip; Surgical Technique
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of May 11, 2016