Osteoarthritis, Hip
Conditions
Keywords
Total Hip Arthroplasty, minimally invasive, Patient-relevant outcomes
Brief summary
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
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?
Interventions
OTHERsurgical approach
Sponsors
Stryker Instruments
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single-center prospective randomized study design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical function hip - Harris-Hip-Score (HHS) | change from baseline (preoperative) at 8 years after THA | Harris-Hip-Score (worst=0, best=100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Level | at 8 years after THA | Satisfaction scale (worst=0, best=10) |
| health related Quality of life - Index | change from baseline (preoperative) at 8 years after THA | EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1) |
| health related Quality of life - VAS | change from baseline (preoperative) at 8 years after THA | EQ-Visual Analogue Scale (worst=0, best=100) |
| Physical function hip - WOMAC | change from baseline (preoperative) at 8 years after THA | WOMAC Total Score (worst=0, best=100) |
| Revision rate | at 8 years after THA | Revision rate using Kaplan-Meier-Survival Analysis |
| Physical Activity Performance Test: walking | change from baseline (preoperative) at 8 years after THA | 25-meter walking time |
| Physical Activity Performance Test: stair climbing | change from baseline (preoperative) at 8 years after THA | 5-step walking time |
| Physical Activity | change from baseline (preoperative) at 8 years after THA | University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10) |
Countries
Germany
Outcome results
None listed