NCT01031732

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
PROCEDURE	MIS-2 THA	MIS two-incision THA
PROCEDURE	MIS-WJ	MIS-Watson Jones THA
PROCEDURE	MIS-AL THA	Transgluteal approach
PROCEDURE	MIS-PL THA	Posterolateral approach

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2009-12-15
• Last updated: 2010-05-31

Locations

1 site across 1 country: Taiwan