Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

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

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.

Study Overview

• Status: Unknown
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Procedure: MIS-2 THA; Procedure: MIS-WJ; Procedure: MIS-AL THA; Procedure: MIS-PL THA

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan
    • Kweishan, Taoyuan, Taiwan, 333
      • Recruiting
      • Chang Gung Memorial Hospital
      • Contact: Mel S Lee, MD, PhD; Phone Number: 886-968372599; Email: mellee@adm.cgmh.org.tw
      • Principal Investigator: Mel S Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Two-incision; MIS-2 THA	Procedure: MIS-2 THA; MIS two-incision THA
Experimental: Watson-Jones; MIS-WJ	Procedure: MIS-WJ; MIS-Watson Jones THA
Experimental: MIS-AL	Procedure: MIS-AL THA; Transgluteal approach
Experimental: MIS-PL	Procedure: MIS-PL THA; Posterolateral approach

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Zimmer Biomet

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• American Academy of Orthopaedic Surgeons
• Chang Gung Memorial Hospital
• Chang Gung University

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: December 13, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): May 31, 2010
• Last Update Submitted That Met QC Criteria: May 27, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Total hip arthroplasty; Minimally invasive; 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.
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Parasympathomimetics; Tacrine
• Other Study ID Numbers: 97-2177c