Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

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Chang Gung Medical Foundation

Status

Unknown

Conditions

Arthroplasty, Replacement, Hip

Treatments

Procedure: MIS-AL THA
Procedure: MIS-PL THA
Procedure: MIS-2 THA
Procedure: MIS-WJ

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01031732
97-2177c

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 4 patient groups

Two-incision
Experimental group
Description:
MIS-2 THA
Treatment:
Procedure: MIS-2 THA
Watson-Jones
Experimental group
Description:
MIS-WJ
Treatment:
Procedure: MIS-WJ
MIS-AL
Experimental group
Treatment:
Procedure: MIS-AL THA
MIS-PL
Experimental group
Treatment:
Procedure: MIS-PL THA

Trial contacts and locations

1

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Central trial contact

Chihling Chou, RN; Mel S Lee, MD, PhD

Data sourced from clinicaltrials.gov

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