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Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01031732
First Posted: December 15, 2009
Last Update Posted: May 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Zimmer Biomet
Information provided by:
Chang Gung Memorial Hospital
December 13, 2009
December 15, 2009
May 31, 2010
November 2009
December 2012   (Final data collection date for primary outcome measure)
Pain and Harris hip score [ Time Frame: 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months ]
Same as current
Complete list of historical versions of study NCT01031732 on ClinicalTrials.gov Archive Site
Functional outcomes assessment [ Time Frame: 6 weeks, 3 months, 6 months, 12 months, 24 months ]
Same as current
Not Provided
Not Provided
 
Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty
A Prospective Randomized Controlled 4-arm Study for the Evaluation of 4 Surgical Techniques in Primary Total Hip Arthroplasty
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Arthroplasty, Replacement, Hip
  • Procedure: MIS-2 THA
    MIS two-incision THA
  • Procedure: MIS-WJ
    MIS-Watson Jones THA
  • Procedure: MIS-AL THA
    Transgluteal approach
  • Procedure: MIS-PL THA
    Posterolateral approach
  • Experimental: Two-incision
    MIS-2 THA
    Intervention: Procedure: MIS-2 THA
  • Experimental: Watson-Jones
    MIS-WJ
    Intervention: Procedure: MIS-WJ
  • Experimental: MIS-AL
    Intervention: Procedure: MIS-AL THA
  • Experimental: MIS-PL
    Intervention: Procedure: MIS-PL THA

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
December 2013
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01031732
97-2177c
Yes
Not Provided
Not Provided
Janet George/Director, Corporate External Research, Zimmer, Inc.
Chang Gung Memorial Hospital
Zimmer Biomet
Not Provided
Chang Gung Memorial Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP