- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03657953
Outcomes 8 Years After Minimal Invasive THA
Patient-relevant Outcomes 8 Years After Minimally Invasive Total Hip Replacement - a Randomized Prospective Study
Study Overview
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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dresden, Germany, 01307
- University Hospital Dresden, Orthopaedic Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: anterior (MI-A) 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.
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Active Comparator: anterolateral (MI-AL) 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.
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Active Comparator: direct lateral (DLA) 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical function hip - Harris-Hip-Score (HHS)
Time Frame: change from baseline (preoperative) at 8 years after THA
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Harris-Hip-Score (worst=0, best=100)
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change from baseline (preoperative) at 8 years after THA
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical function hip - WOMAC
Time Frame: change from baseline (preoperative) at 8 years after THA
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WOMAC Total Score (worst=0, best=100)
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change from baseline (preoperative) at 8 years after THA
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Satisfaction Level
Time Frame: at 8 years after THA
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Satisfaction scale (worst=0, best=10)
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at 8 years after THA
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health related Quality of life - Index
Time Frame: change from baseline (preoperative) at 8 years after THA
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EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1)
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change from baseline (preoperative) at 8 years after THA
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health related Quality of life - VAS
Time Frame: change from baseline (preoperative) at 8 years after THA
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EQ-Visual Analogue Scale (worst=0, best=100)
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change from baseline (preoperative) at 8 years after THA
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Physical Activity
Time Frame: change from baseline (preoperative) at 8 years after THA
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University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)
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change from baseline (preoperative) at 8 years after THA
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Revision rate
Time Frame: at 8 years after THA
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Revision rate using Kaplan-Meier-Survival Analysis
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at 8 years after THA
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Physical Activity Performance Test: walking
Time Frame: change from baseline (preoperative) at 8 years after THA
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25-meter walking time
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change from baseline (preoperative) at 8 years after THA
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Physical Activity Performance Test: stair climbing
Time Frame: change from baseline (preoperative) at 8 years after THA
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5-step walking time
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change from baseline (preoperative) at 8 years after THA
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maik Stiehler, MD, University Center for Orthopaedics and Trauma Surgery, University Hospital Carl Gustav
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THA MIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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