Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

Chang Gung Medical Foundation

Status: Unknown

Conditions: Arthroplasty, Replacement, Hip

Treatments: Procedure: MIS-PL THA; Procedure: MIS-2 THA; Procedure: MIS-AL 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

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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