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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01031732
Other study ID # 97-2177c
Secondary ID
Status Recruiting
Phase N/A
First received December 13, 2009
Last updated May 27, 2010
Start date November 2009
Est. completion date December 2013

Study information

Verified date May 2010
Source Chang Gung Memorial Hospital
Contact Mel S Lee, MD, PhD
Phone 886-968372599
Email mellee@adm.cgmh.org.tw
Is FDA regulated No
Health authority Taiwan: CRO Division, Formosa Biomedical Technology Corp.
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
MIS-2 THA
MIS two-incision THA
MIS-WJ
MIS-Watson Jones THA
MIS-AL THA
Transgluteal approach
MIS-PL THA
Posterolateral approach

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Kweishan Taoyuan

Sponsors (2)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital Zimmer, Inc.

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Chen DW, Hu CC, Chang YH, Yang WE, Lee MS. Comparison of clinical outcome in primary total hip arthroplasty by conventional anterolateral transgluteal or 2-incision approach. J Arthroplasty. 2009 Jun;24(4):528-32. doi: 10.1016/j.arth.2008.03.016. Epub 2008 Aug 3. — View Citation

Chou SW, Ueng SW, Lee MS. Muscular recovery of hip flexors and extensors after two-incision total hip arthroplasty. Chang Gung Med J. 2008 Nov-Dec;31(6):576-82. — View Citation

Hu CC, Yang WE, Chang YH, Chen DW, Ueng SW, Lee MS. Fluoroscopy cannot recognize intraoperative fracture in patients receiving 2-incision total hip arthroplasty. J Arthroplasty. 2008 Oct;23(7):1031-6. doi: 10.1016/j.arth.2007.09.026. Epub 2008 Mar 4. — View Citation

Lee MS, Kuo CH, Senan V, Chen WJ, Chen LH, Ueng SW. Two-incision total hip replacement: Intra-operative fluoroscopy versus imageless navigation for cup placement. Hip Int. 2006;16 Suppl 4:35-41. — View Citation

Lu ML, Chou SW, Yang WE, Senan V, Hsieh PH, Shih HN, Lee MS. Hospital course and early clinical outcomes of two-incision total hip arthroplasty. Chang Gung Med J. 2007 Nov-Dec;30(6):513-20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain and Harris hip score 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months No
Secondary Functional outcomes assessment 6 weeks, 3 months, 6 months, 12 months, 24 months No
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