Hip Osteoarthritis Clinical Trial
Official title:
Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty: a Biochemical, Imaging and Clinical Evaluation in the Early Postoperative Period
NCT number | NCT04311125 |
Other study ID # | 4 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2020 |
Est. completion date | May 1, 2022 |
Total hip arthroplasty is a method of choice for treating advanced osteoarthritis of the hip and one of the most frequent orthopedic procedures. Of all hip surgical approaches described, the tendency for minimally invasive techniques has been dominated over the last few years due to faster patient mobilization, reduced postoperative pain and need for blood transfusion. Two of the most common approaches used for minimally invasive total hip arthroplasty are: AMIS anterior approach and mini-posterior approach, which is a modification of the standard posterior approach. The purpose of this study is the biochemical, imaging and clinical evaluation of the tissue damage caused by the above-mentioned techniques of minimally invasive total hip arthroplasty.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | May 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients that sign the Informed consent - Patients aged 18 years and over who are going to undergo primary total hip arthroplasty Exclusion Criteria: I. Active infection II. Previous hip operation in any leg III. Any kind of operation the past 3 months IV. Obesity (BMI, Body Mass Index >30) V. Autoimmune diseases or myositis of any etiology VI. Active cancer |
Country | Name | City | State |
---|---|---|---|
Greece | 2nd Department of Orthopaedics | Athens | Attika |
Lead Sponsor | Collaborator |
---|---|
National and Kapodistrian University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tissue damage change | Investigate and quantify at the biochemical level with all available biomarkers the extent of tissue damage caused during a hip arthroplasty between different hip surgical approaches. | Change from 6 to 24 and then 48 hours post-surgery | |
Secondary | Imaging | All patients will be subjected to imaging with a hip MRI | Day 30 after surgery | |
Secondary | Clinical Tests change | All patients will be monitored postoperatively for the prescribed period and data will be recorded. | Change to clinical test from Day 2 to day 15 and then day 30 post-surgery |
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