- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05255198
Anterior Minimal Invasive Surgery Versus Antero-lateral Approach in Hip Joint Hemiarthroplasty
February 15, 2022 updated by: Renate Krassnig MD PhD, Rehabilitation Hospital Tobelbad
Comparison between two minimally invasive approaches to the hip joint.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Following parameters were compared: modified Barthel-Index, pain, complications, developing of heterotopic ossification.
Study Type
Observational
Enrollment (Actual)
83
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All consecutive patients, presenting with indication for bipolar hemiarthroplasty of the hip joint due to Garden III and IV fractures, who had given their written informed consent, were enrolled in the study.
Exclusion
Description
Exclusion Criteria:
Exclusion criteria represented acute local or systemic infection, open or pathological fractures, concomitant injuries of the ipsi- or contralateral leg and rheumatoid arthritis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Anterolateral approach
|
|
|
Direct anterior approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: one year after surgery
|
Pain score
|
one year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
August 30, 2021
First Submitted That Met QC Criteria
February 15, 2022
First Posted (Actual)
February 24, 2022
Study Record Updates
Last Update Posted (Actual)
February 24, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- HHAP$1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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