ArthroplastyNCT05255198
Anterior Minimal Invasive Surgery Versus Antero-lateral Approach in Hip Joint Hemiarthroplasty
An observational study of Arthroplasty and Clinical Outcome, run by Rehabilitation Hospital Tobelbad.
Trial summary
Comparison between two minimally invasive approaches to the hip joint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Clinical Outcome
- What is being tested?
- Anterior versus lateral approach to hip joint
- Type of treatment
- Surgery or procedure
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 31 May 2019
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
None listed.
Who cannot join
- Exclusion criteria represented acute local or systemic infection, open or pathological fractures, concomitant injuries of the ipsi- or contralateral leg and rheumatoid arthritis.
About this study
Comparison between two minimally invasive approaches to the hip joint.
Read the detailed description
Following parameters were compared: modified Barthel-Index, pain, complications, developing of heterotopic ossification.
- Conditions
- Arthroplasty, Clinical Outcome
- Being tested
- Anterior versus lateral approach to hip joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior versus lateral approach to hip jointProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Anterolateral approach | Not described Receives: Procedure: Anterior versus lateral approach to hip joint | |
| Direct anterior approach | Not described Receives: Procedure: Anterior versus lateral approach to hip joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain score
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 May 2016
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Rehabilitation Hospital Tobelbad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renate Krassnig MD PhD, Rehabilitation Hospital Tobelbad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255198
- Sponsor's protocol ID
- HHAP$1
- Status last verified
- Feb 2022
- First submitted
- 30 Aug 2021
- Last updated
- 24 Feb 2022
- 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 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Minimal Invasive Surgery Versus Antero-lateral Approach in Hip Joint Hemiarthroplasty
- ClinicalTrials.gov ID
- NCT05255198
- Acronym / sponsor ID
- HHAP$1
- Conditions
- Arthroplasty, Clinical Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Rehabilitation Hospital TobelbadUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 24 Feb 2022 (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.
Comparison between two minimally invasive approaches to the hip joint.
Detailed description
Following parameters were compared: modified Barthel-Index, pain, complications, developing of heterotopic ossification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterolateral approach | – | Procedure: Anterior versus lateral approach to hip joint |
| Direct anterior approach | – | Procedure: Anterior versus lateral approach to hip joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Exclusion criteria represented acute local or systemic infection, open or pathological fractures, concomitant injuries of the ipsi- or contralateral leg and rheumatoid arthritis.
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 |
|---|---|---|
| Anterior versus lateral approach to hip joint | Procedure or surgery | Anterolateral approach, Direct anterior approach |
Primary outcome
Visual Analogue Scale
Time frame: one year after surgery
Pain score
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 24 Feb 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty and Clinical Outcome, run by Rehabilitation Hospital Tobelbad.
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 0 inclusion and 1 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 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual Analogue Scale (time frame: one year after surgery). 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 24 Feb 2022.