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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
Zimmer Biomet
Information provided by:
Chang Gung Memorial Hospital Identifier:
First received: December 13, 2009
Last updated: May 27, 2010
Last verified: May 2010
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
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

Resource links provided by NLM:

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 ]

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

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
Procedure: MIS-2 THA
MIS two-incision THA
Experimental: Watson-Jones
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.

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

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
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Please refer to this study by its identifier: NCT01031732

Contact: Mel S Lee, MD, PhD 886-968372599
Contact: Chihling Chou, RN 886-968419384

Chang Gung Memorial Hospital Recruiting
Kweishan, Taoyuan, Taiwan, 333
Contact: Mel S Lee, MD, PhD    886-968372599   
Principal Investigator: Mel S Lee, MD, PhD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Zimmer Biomet
  More Information

Additional Information:
Responsible Party: Janet George/Director, Corporate External Research, Zimmer, Inc. Identifier: NCT01031732     History of Changes
Other Study ID Numbers: 97-2177c
Study First Received: December 13, 2009
Last Updated: May 27, 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. processed this record on September 21, 2017