Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

Not Applicable

• Conditions: Arthroplasty, Replacement, Hip
• Interventions: Procedure: MIS-2 THA; Procedure: MIS-WJ; Procedure: MIS-AL THA; Procedure: MIS-PL THA

• Registration Number: NCT01031732
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-13
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-27
• Last Update Posted: 2010-05-31
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two-incision	MIS-2 THA	MIS-2 THA
Watson-Jones	MIS-WJ	MIS-WJ
MIS-AL	MIS-AL THA	-
MIS-PL	MIS-PL THA	-

Primary Outcome Measures

Name	Time	Method
Pain and Harris hip score	5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months

Secondary Outcome Measures

Name	Time	Method
Functional outcomes assessment	6 weeks, 3 months, 6 months, 12 months, 24 months

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kweishan, Taoyuan, Taiwan