- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02645435
Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement
Background:
Direct anterior approach to the hip (DAA) is being considered as one of the most promising minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to analyse influence of learning curve on clinical and radiographic outcome in direct anterior approach (DAA) for total hip replacement.
Methods:
The first 30 patients operated with DAA (group B) were compared to 39 patients operated by Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS), implant positioning, experienced pain and patient satisfaction were evaluated at a mean follow-up of 32 months.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Direct anterior approach to the hip (DAA) is being considered as one of the most promising minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to analyse influence of learning curve on clinical and radiographic outcome in direct anterior approach (DAA) for total hip replacement.
Methods:
The first 30 patients operated with DAA (group B) were compared to 39 patients operated by Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS), implant positioning, experienced pain and patient satisfaction were evaluated at a mean follow-up of 32 months.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hip arthritis
Exclusion Criteria:
- BMI>35
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Hip direct anterior approach
Patients with hip arthritis
|
Total hip replacement
|
|
Active Comparator: Lateral hip approach
Patients with hip arthritis
|
Total hip replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical outcome of direct hip approach
Time Frame: 32 months
|
Harry's hip score, a clinical score used in orthopedic surgery to describe outcome of hip function
|
32 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
radiological positioning of cup in the replaced hip
Time Frame: 32 months
|
using standard x-ray of the hip placement of implants is measured in angles between the iliac line and component line for the cup
|
32 months
|
|
radiological positioning of the stem in replaced hip
Time Frame: 32 months
|
using standard x-ray of the hip placement of implants is measured in angles between the axis of implant and femoral axis
|
32 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AObolognini1
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