Evaluation of Four Surgical Techniques in Primary Total H... | NCT01031732

Studies
Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

NCT01031732

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

May 31, 2010Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Arthroplasty, Replacement, Hip

Interventions

MIS-2 THA
MIS-WJ
MIS-AL THA
MIS-PL THA

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Dec 13, 2009

First Submission Date that Met QC Criteria

Dec 14, 2009

First Posted Date

Dec 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2010

Last Update Posted Date

May 31, 2010Estimated

Name	Class
Zimmer Biomet	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

Arthroplasty, Replacement, Hip

Keywords

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
MIS-2 THA	Procedure	MIS two-incision THA	Two-incision
MIS-WJ

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain and Harris hip score		5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months

Secondary Outcomes

Measure	Description	Time Frame
Functional outcomes assessment		6 weeks, 3 months, 6 months, 12 months, 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mel S Lee, MD, PhD	Contact	886-968372599		mellee@adm.cgmh.org.tw
Chihling Chou, RN	Contact	886-968419384		chihling0930@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital	Recruiting	Kweishan	Taoyuan	333	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19241897	Background	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.
18676112	Background	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.