Outcomes 8 Years After Minimal Invasive THA
- Conditions
- Osteoarthritis, Hip
- Interventions
- Other: surgical approach
- Registration Number
- NCT03657953
- Lead Sponsor
- Technische Universität Dresden
- 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?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
- clinical and radiologic signs of advanced hip joint Degeneration
- Patients from age 18 to 75
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description anterior (MI-A) surgical approach surgical approach 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. anterolateral (MI-AL) surgical approach surgical approach 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. direct lateral (DLA) surgical approach surgical approach 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
- Primary Outcome Measures
Name Time Method Physical function hip - Harris-Hip-Score (HHS) change from baseline (preoperative) at 8 years after THA Harris-Hip-Score (worst=0, best=100)
- Secondary Outcome Measures
Name Time Method 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 Activity change from baseline (preoperative) at 8 years after THA University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)
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 function hip - WOMAC change from baseline (preoperative) at 8 years after THA WOMAC Total Score (worst=0, best=100)
Satisfaction Level at 8 years after THA Satisfaction scale (worst=0, best=10)
Trial Locations
- Locations (1)
University Hospital Dresden, Orthopaedic Department
🇩🇪Dresden, Germany