THANCT06430723
The Impact of Obesity on Short Stem Total Hip Arthroplasty
An observational study of THA and Obesity, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
Trial summary
The purpose of this study is to review the impact of obesity on subsidence and clinical outcome after short stem total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2018to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The purpose of this study was to assess the subsidence rates in patients who underwent short stem hip arthroplasty and its association with obesity. To investigate this, an analysis of patient data was conducted together with a follow-up examination, focusing on clinical outcome and radiographic analysis of the subsidence of the stem in obese patients. Hence, two groups based on body mass index were retrospectively evaluated: obese (BMI ≥ 30 kg/m^2) and non-obese (BMI < 30 kg/m^2), with an age of minimum 18 years, but no maximum age.
Who may be able to join
- patients who underwent primary short stem hip arthroplasty with Mathys Optimys short stem between 01.01.2018 and 31.12.2020
- availability of preoperative and postoperative radiographs for assessment of subsidence
- a minimum BMI of 30kg/m2 for the obese group
- a minimum follow-up of 24 months.
Who cannot join
- former surgeries of the hip in question
- incomplete clinical data
- incomplete radiological data
Trial locations and contacts
1 site in 1 country.
Austria1 site
Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie
Linz, 4010
About this study
Official title: Obesity and it's Impact on Subsidence and Clinical Outcomes After Short Stem Total Hip
The purpose of this study is to review the impact of obesity on subsidence and clinical outcome after short stem total hip arthroplasty.
Read the detailed description
Short stem total hip arthroplasty (THA) has gained popularity due to its bone-sparing technique, but its outcomes in obese patients remain uncertain.
While studies on the mid-term outcome in a general patient cohort provide excellent results in terms of the clinical and radiological outcome as well as the complication rate of short stem THA, data on its use in obese patients is still rare and not sufficiently conclusive. Some studies have found no evidence of increased subsidence in obese patients, while other studies have shown contrary trends.
In this context, the aim of this study was to investigate the relationship between BMI, postoperative subsidence and clinical outcomes in the setting of short stem THA.
- Being tested
- Total hip arthroplasty
- Keywords
- subsidence, obesity, short stem total hip arthroplasty, tha
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyProcedure or surgery
Total hip arthroplasty using short stem via an minimally invasive anterolateral approach
| Study group | Role | What they receive |
|---|---|---|
| Non-obese | Body mass index < 30 kg/m2 Receives: Procedure: Total hip arthroplasty | |
| Obese | Body mass index >= 30 kg/m2 Receives: Procedure: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subsidence
subsidence of the short stem measured via EBRA (Einzelbild Röntgenanalyse), [mm]
Measured: 2 years
Harris Hip Score
Clinical outcome, [0-100points]
Measured: 2 years
Secondary outcomes (3)
surgery time
Surgery time from cut to skin closure, [minutes]
Measured: 2 years
Length of stay
Length of postoperative stay in hospital [days]
Measured: 2 years
Blood loss
Blood loss calculated according to laboratory test results of hematocrit [ml]
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430723
- Sponsor's protocol ID
- EK 1258/2023
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and it's Impact on Subsidence and Clinical Outcomes After Short Stem Total Hip
- ClinicalTrials.gov ID
- NCT06430723
- Acronym / sponsor ID
- EK 1258/2023
- Keywords
- subsidence, obesity, short stem total hip arthroplasty, tha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to review the impact of obesity on subsidence and clinical outcome after short stem total hip arthroplasty.
Detailed description
Short stem total hip arthroplasty (THA) has gained popularity due to its bone-sparing technique, but its outcomes in obese patients remain uncertain.
While studies on the mid-term outcome in a general patient cohort provide excellent results in terms of the clinical and radiological outcome as well as the complication rate of short stem THA, data on its use in obese patients is still rare and not sufficiently conclusive. Some studies have found no evidence of increased subsidence in obese patients, while other studies have shown contrary trends.
In this context, the aim of this study was to investigate the relationship between BMI, postoperative subsidence and clinical outcomes in the setting of short stem THA.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-obese | – | Procedure: Total hip arthroplastyBody mass index < 30 kg/m2 |
| Obese | – | Procedure: Total hip arthroplastyBody mass index >= 30 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The purpose of this study was to assess the subsidence rates in patients who underwent short stem hip arthroplasty and its association with obesity. To investigate this, an analysis of patient data was conducted together with a follow-up examination, focusing on clinical outcome and radiographic analysis of the subsidence of the stem in obese patients. Hence, two groups based on body mass index were retrospectively evaluated: obese (BMI ≥ 30 kg/m^2) and non-obese (BMI < 30 kg/m^2), with an age of minimum 18 years, but no maximum age.
Key inclusion criteria (4 listed)
- patients who underwent primary short stem hip arthroplasty with Mathys Optimys short stem between 01.01.2018 and 31.12.2020
- availability of preoperative and postoperative radiographs for assessment of subsidence
- a minimum BMI of 30kg/m2 for the obese group
- a minimum follow-up of 24 months.
Key exclusion criteria (3 listed)
- former surgeries of the hip in question
- incomplete clinical data
- incomplete radiological data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip arthroplastyTotal hip arthroplasty using short stem via an minimally invasive anterolateral approach | Procedure or surgery | Non-obese, Obese |
Primary outcome
Subsidence
Time frame: 2 years
subsidence of the short stem measured via EBRA (Einzelbild Röntgenanalyse), [mm]
Harris Hip Score
Time frame: 2 years
Clinical outcome, [0-100points]
3 secondary outcomes
surgery time
Time frame: 2 years
Length of stay
Time frame: 2 years
Blood loss
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of THA and Obesity, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subsidence (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.