NCT01031732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 31, 2010

Status Verified

May 1, 2010

Enrollment Period

3.1 years

First QC Date

December 13, 2009

Last Update Submit

May 27, 2010

Conditions

Arthroplasty, Replacement, Hip

Keywords

Minimally invasiveTotal hip arthroplastyFunctional outcomeTo compare the surgical results of 4 MIS THA techniquesTo investigate the functional outcomes of 4 MIS THA techniquesTo study the biochemical parameters after the MIS surgeries.

Outcome Measures

Primary Outcomes (1)

  • Pain and Harris hip score

    5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months

Secondary Outcomes (1)

  • Functional outcomes assessment

    6 weeks, 3 months, 6 months, 12 months, 24 months

Study Arms (4)

Two-incision

EXPERIMENTAL

MIS-2 THA

Procedure: MIS-2 THA

Watson-Jones

EXPERIMENTAL

MIS-WJ

Procedure: MIS-WJ

MIS-AL

EXPERIMENTAL
Procedure: MIS-AL THA

MIS-PL

EXPERIMENTAL
Procedure: MIS-PL THA

Interventions

MIS-2 THAPROCEDURE

MIS two-incision THA

Two-incision
MIS-WJPROCEDURE

MIS-Watson Jones THA

Watson-Jones
MIS-AL THAPROCEDURE

Transgluteal approach

MIS-AL
MIS-PL THAPROCEDURE

Posterolateral approach

MIS-PL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral hip disease that is indicated for primary total hip arthroplasty.

You may not qualify if:

  • A previous THA on the contralateral hip.
  • Any condition contraindicated for primary total hip arthroplasty.
  • Refuse to be randomized in the study arms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kweishan, Taoyuan, 333, Taiwan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 19241897BACKGROUND

  • 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.

    PMID: 18676112BACKGROUND

  • 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.

    PMID: 18534477BACKGROUND

  • 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.

    PMID: 18350734BACKGROUND

  • 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.

    PMID: 19219827BACKGROUND

Related Links

Central Study Contacts

Mel S Lee, MD, PhD

CONTACT

886-968372599mellee@adm.cgmh.org.tw

Chihling Chou, RN

CONTACT

886-968419384chihling0930@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2009

First Posted

December 15, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

May 31, 2010

Record last verified: 2010-05

Locations

TW(1)