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Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

NCT ID: NCT01031732

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Arthroplasty, Replacement, Hip

Keywords

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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.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Two-incision

MIS-2 THA

Group Type EXPERIMENTAL

MIS-2 THA

Intervention Type PROCEDURE

MIS two-incision THA

Watson-Jones

MIS-WJ

Group Type EXPERIMENTAL

MIS-WJ

Intervention Type PROCEDURE

MIS-Watson Jones THA

MIS-AL

Group Type EXPERIMENTAL

MIS-AL THA

Intervention Type PROCEDURE

Transgluteal approach

MIS-PL

Group Type EXPERIMENTAL

MIS-PL THA

Intervention Type PROCEDURE

Posterolateral approach

Interventions

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MIS-2 THA

MIS two-incision THA

Intervention Type PROCEDURE

MIS-WJ

MIS-Watson Jones THA

Intervention Type PROCEDURE

MIS-AL THA

Transgluteal approach

Intervention Type PROCEDURE

MIS-PL THA

Posterolateral approach

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zimmer, Inc.

Locations

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Chang Gung Memorial Hospital

Kweishan, Taoyuan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Mel S Lee, MD, PhD

Role: CONTACT

Phone: 886-968372599

Email: [email protected]

Chihling Chou, RN

Role: CONTACT

Phone: 886-968419384

Email: [email protected]

Facility Contacts

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Mel S Lee, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19241897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18676112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18534477 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18350734 (View on PubMed)

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. doi: 10.1177/112070000601604S08.

Reference Type BACKGROUND
PMID: 19219827 (View on PubMed)

Related Links

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http://www.cgmh.org.tw

Chang Gung Memorial Hospital

http://www.AAOS.org

American Academy of Orthopaedic Surgeons

http://www.cgu.edu.tw

Chang Gung University

Other Identifiers

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97-2177c

Identifier Type: -

Identifier Source: org_study_id