Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty

Study Overview
=================
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.

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

Conditions
-----------------
Arthroplasty, Replacement, Hip

Intervention / Treatment
-----------------
* Procedure: MIS-2 THA
* Procedure: MIS-WJ
* Procedure: MIS-AL THA
* Procedure: MIS-PL THA


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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.