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Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT01031732
Recruitment Status : Unknown
Verified May 2010 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : December 15, 2009
Last Update Posted : May 31, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Current "Minimally Invasive THR" includes: (1) Minimally Invasive Two-Incision THR (MIS-2), (2) Minimally Invasive Modified Watson-Jones THR (MIS-WJ). In contrast, "mini-incision" utilizes smaller incision (< 10 cm in definition) to perform the THR which can further be divided into mini-anterolateral (Mini-AL) and mini-posterolateral (Mini-PL).The purpose of this study is to investigate how MIS THR can affect the results of THR by a prospective randomized clinical trial. It is hoped that some new standards could be established for the total hip replacement surgery.

Condition or disease Intervention/treatment
Arthroplasty, Replacement, Hip Procedure: MIS-2 THA Procedure: MIS-WJ Procedure: MIS-AL THA Procedure: MIS-PL THA

Detailed Description:
The prospective randomized study will be performed in patients after obtaining patient's consent. "Envelop drawing based on random table" will decide the choice of approach. (1) Group 1: MIS-2, 30 cases (2) Group 2: MIS-WJ, 30 cases (3) Group 3: Mini-AL, 30 cases (4) Group 4: Mini-PL, 30 cases. Only the unilateral coxarthrosis will be recruited for the study. Analytical methods include (1) gait analysis (2) cybex study (3) balance test and obstacle crossing test (4) bone densitometry (5) PETS oxygen consumption and glucose utilization tests (6) inflammatory markers (7) clinical assessment (8) X-ray studies. Patients will be scheduled for specified examinations preoperatively, postoperatively and within 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, and 36 months.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled 4-arm Study for the Evaluation of 4 Surgical Techniques in Primary Total Hip Arthroplasty
Study Start Date : November 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Two-incision
MIS-2 THA
Procedure: MIS-2 THA
MIS two-incision THA
Experimental: Watson-Jones
MIS-WJ
Procedure: MIS-WJ
MIS-Watson Jones THA
Experimental: MIS-AL Procedure: MIS-AL THA
Transgluteal approach
Experimental: MIS-PL Procedure: MIS-PL THA
Posterolateral approach


Outcome Measures

Primary Outcome Measures :
  1. Pain and Harris hip score [ Time Frame: 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months ]

Secondary Outcome Measures :
  1. Functional outcomes assessment [ Time Frame: 6 weeks, 3 months, 6 months, 12 months, 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral hip disease that is indicated for primary total hip arthroplasty.

Exclusion Criteria:

  • A previous THA on the contralateral hip.
  • Any condition contraindicated for primary total hip arthroplasty.
  • Refuse to be randomized in the study arms.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031732


Contacts
Contact: Mel S Lee, MD, PhD 886-968372599 mellee@adm.cgmh.org.tw
Contact: Chihling Chou, RN 886-968419384 chihling0930@yahoo.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Kweishan, Taoyuan, Taiwan, 333
Contact: Mel S Lee, MD, PhD    886-968372599    mellee@adm.cgmh.org.tw   
Principal Investigator: Mel S Lee, MD, PhD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Zimmer Biomet
More Information

Additional Information:
Publications:
Responsible Party: Janet George/Director, Corporate External Research, Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT01031732     History of Changes
Other Study ID Numbers: 97-2177c
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: May 31, 2010
Last Verified: May 2010

Keywords provided by Chang Gung Memorial Hospital:
Minimally invasive
Total hip arthroplasty
Functional outcome
To compare the surgical results of 4 MIS THA techniques
To investigate the functional outcomes of 4 MIS THA techniques
To study the biochemical parameters after the MIS surgeries.