Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

A Prospective Randomized Controlled 4-arm Study for the Evaluation of 4 Surgical Techniques in Primary Total Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01031732
• Other study ID #: 97-2177c
• 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

• Arthroplasty, Replacement, Hip

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

External Links

•   American Academy of Orthopaedic Surgeons
•   Chang Gung University