Clinical trial NCT03657953: Outcomes 8 Years After Minimal Invasive THA
Official title: Patient-relevant Outcomes 8 Years After Minimally Invasive Total Hip Replacement - a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Total Hip Arthroplasty
minimally invasive
Patient-relevant outcomes
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Stryker Instruments
First posted: 2018-09-05
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center prospective randomized study design
Primary purpose: TREATMENT

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?

Eligibility criteria: 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

Primary outcomes:
measure: Physical function hip - Harris-Hip-Score (HHS)
timeFrame: change from baseline (preoperative) at 8 years after THA
Secondary outcomes:
measure: Physical function hip - WOMAC
timeFrame: change from baseline (preoperative) at 8 years after THA
measure: Satisfaction Level
timeFrame: at 8 years after THA
measure: health related Quality of life - Index
timeFrame: change from baseline (preoperative) at 8 years after THA
measure: health related Quality of life - VAS
timeFrame: change from baseline (preoperative) at 8 years after THA
measure: Physical Activity
timeFrame: change from baseline (preoperative) at 8 years after THA
measure: Revision rate
timeFrame: at 8 years after THA
measure: Physical Activity Performance Test: walking
timeFrame: change from baseline (preoperative) at 8 years after THA
measure: Physical Activity Performance Test: stair climbing
timeFrame: change from baseline (preoperative) at 8 years after THA
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Dresden, Orthopaedic Department
Study officials:
affiliation: University Center for Orthopaedics and Trauma Surgery, University Hospital Carl Gustav
name: Maik Stiehler, MD
role: PRINCIPAL_INVESTIGATOR
References: