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Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

This study is currently recruiting participants.
Verified May 2010 by Chang Gung Memorial Hospital
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01031732
First received: December 13, 2009
Last updated: May 27, 2010
Last verified: May 2010
History of Changes
  Purpose

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 Intervention
Arthroplasty, Replacement, Hip
 Procedure: MIS-2 THA
Procedure: MIS-WJ
Procedure: MIS-AL THA
Procedure: MIS-PL THA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

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

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Pain and Harris hip score [ Time Frame: 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional outcomes assessment [ Time Frame: 6 weeks, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, Inc.
  More Information

Additional Information:
Chang Gung Memorial Hospital  This link exits the ClinicalTrials.gov site
American Academy of Orthopaedic Surgeons  This link exits the ClinicalTrials.gov site
Chang Gung University  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Janet George/Director, Corporate External Research, Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT01031732     History of Changes
Other Study ID Numbers: 97-2177c
Study First Received: December 13, 2009
Last Updated: May 27, 2010
Health Authority: Taiwan: CRO Division, Formosa Biomedical Technology Corp.

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.

Additional relevant MeSH terms:
Tacrine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
 Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013