Outcomes 8 Years After Minimal Invasive THA

Study Overview
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Brief Summary
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There exists only limited scientific evidence concerning medium- to long-term benefits concerning minimally invasive (MI) total hip arthroplasty (THA). The investigators examined in a randomized study design 157 patients 8 years after THA, which were performed via 3 different surgical approaches.

Detailed Description
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In contrast to reported short-term advantages of minimally invasive (MI) total hip arthroplasty (THA) there exists only limited scientific evidence concerning medium- to long-term benefits. The investigators therefore sought to answer the following questions: Is the functional medium-term outcome in THA patients with MI-anterior(MI-A) and MI-anterolateral (MI-AL) approach superior to those treated by direct lateral approach (DLA)? Is the level of life quality increased by MI-THA? Is patient satisfaction higher by MI-THA? Is the revision rate reduced by MI-THA?

Official Title
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Patient-relevant Outcomes 8 Years After Minimally Invasive Total Hip Replacement - a Randomized Prospective Study

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Other: surgical approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical and radiologic signs of advanced hip joint Degeneration Patients from age 18 to 75 Exclusion Criteria: osteoporosis and osteomalacia, preceding surgery or radiation therapy in the proximity of the affected hip joint, progressive neoplasia, preceding or manifest infection of the affected joint and its surrounding soft tissues, rheumatoid arthritis, hip dysplasia Hartofilakidis type 2 or 3, non-compliance, chronic neurological or psychiatric diseases, ongoing pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-center prospective randomized study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anterior (MI-A) surgical approach<br>The minimally invasive anterior surgical approach was carried out using a modified Smith-Petersen access as described by Bender et al. (Bender et al. 2009) with the patient in supine position. | Other: surgical approach<br> <br> |
| Active Comparator: anterolateral (MI-AL) surgical approach<br>For the minimally invasive anterolateral surgical approach, a modified Watson-Jones approach according to Röttinger (Rottinger et al. 2006) was applied with the patient in supine position. | Other: surgical approach<br> <br> |
| Active Comparator: direct lateral (DLA) surgical approach<br>The direct lateral surgical approach was performed according to the technique described by Hardinge et al. (Hardinge et al. 1982) with the patient positioned supine | Other: surgical approach<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function hip - Harris-Hip-Score (HHS) | Harris-Hip-Score (worst=0, best=100) | change from baseline (preoperative) at 8 years after THA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function hip - WOMAC | WOMAC Total Score (worst=0, best=100) | change from baseline (preoperative) at 8 years after THA | 
| Satisfaction Level | Satisfaction scale (worst=0, best=10) | at 8 years after THA | 
| health related Quality of life - Index | EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1) | change from baseline (preoperative) at 8 years after THA | 
| health related Quality of life - VAS | EQ-Visual Analogue Scale (worst=0, best=100) | change from baseline (preoperative) at 8 years after THA | 
| Physical Activity | University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10) | change from baseline (preoperative) at 8 years after THA | 
| Revision rate | Revision rate using Kaplan-Meier-Survival Analysis | at 8 years after THA | 
| Physical Activity Performance Test: walking | 25-meter walking time | change from baseline (preoperative) at 8 years after THA | 
| Physical Activity Performance Test: stair climbing | 5-step walking time | change from baseline (preoperative) at 8 years after THA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Arthroplasty, minimally invasive, Patient-relevant outcomes