Total Hip ArthroplastyNCT06141928
Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty
A study testing Functional recovery analysis in people with Total Hip Arthroplasty and Functional Recovery, run by Clinic for Orthopedics Lovran at 1 site in Croatia.
Trial summary
This study aimed to determine differences in functional recovery after total hip arthroplasty between a group of patients operated on using a direct lateral approach, an anterolateral minimally invasive approach, and a posterior approach to the hip joint. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Total Hip Arthroplasty, Functional Recovery
- What is being tested?
- Functional recovery analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Sep 2021to 31 Dec 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- hip osteoarthritis
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Clinic for Orthopeadics and Traumatology Lovran
Lovran, Primorje-Gorski Kotar County, 51145
Tomislav Prpic, PhD, MD, +38598461143, tomislav.prpic317@gmail.com
Antea Buterin, MD
About this study
This study aimed to determine differences in functional recovery after total hip arthroplasty between a group of patients operated on using a direct lateral approach, an anterolateral minimally invasive approach, and a posterior approach to the hip joint.
Arthroplasty is the most commonly performed surgical procedure in orthopedics and is also considered the gold standard for treating the final stage of osteoarthritis. There are several different approaches, but there are still conflicting studies that talk about the benefits of a particular approach. There is an insufficient number of scientific, prospective studies that monitor the basic functional and rehabilitation parameters, which are also indicators of the success of the performed procedure.
- Conditions
- Total Hip Arthroplasty, Functional Recovery
- Being tested
- Functional recovery analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional recovery analysisOther
Functional recovery analysis with force evaluator \& tester
| Study group | Role | What they receive |
|---|---|---|
| Functional Recovery | Other | Not described Receives: Other: Functional recovery analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional recovery after total hip arthroplasty / Range of motion
Investigators analyze active and passive range of motion (ROM) measured in degrees.
Measured: 2 years
Functional recovery after total hip arthroplasty / Walking speed
Investigators analyze walking speed in seconds for the 50 meters long walk.
Measured: 2 years
Functional recovery after total hip arthroplasty / Harris Hip Score
Investigators take a questionnaire (Harris Hip Score, HHS), the maximum point is 100.
Measured: 2 years
Functional recovery after total hip arthroplasty / Hip abductors strength
Investigators analyze hip abductors strength measured with a dynamometer in kilograms (kg).
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 posted21 Nov 2023
- Study start1 Sep 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinic for Orthopedics Lovran
- Sponsor type
- University, hospital or other
- Collaborators
- Special Hospital for Orthopedics Biograd na Moru
- Responsible party
- Principal investigator, Antea Buterin, Clinic for Orthopedics Lovran
- Investigators
- Antea Buterin, MD, Principal investigator, Clinic OL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141928
- Sponsor's protocol ID
- Clinic OL
- Status last verified
- Nov 2023
- First submitted
- 20 Feb 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06141928
- Acronym / sponsor ID
- Clinic OL
- Conditions
- Total Hip Arthroplasty, Functional Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinic for Orthopedics LovranUniversity, hospital or other
- Collaborators
- Special Hospital for Orthopedics Biograd na Moru
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Nov 2023 (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.
This study aimed to determine differences in functional recovery after total hip arthroplasty between a group of patients operated on using a direct lateral approach, an anterolateral minimally invasive approach, and a posterior approach to the hip joint.
Arthroplasty is the most commonly performed surgical procedure in orthopedics and is also considered the gold standard for treating the final stage of osteoarthritis. There are several different approaches, but there are still conflicting studies that talk about the benefits of a particular approach. There is an insufficient number of scientific, prospective studies that monitor the basic functional and rehabilitation parameters, which are also indicators of the success of the performed procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Recovery | Other | Other: Functional recovery analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- hip osteoarthritis
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Functional recovery analysisFunctional recovery analysis with force evaluator \& tester | Other | Functional Recovery |
Primary outcome
Functional recovery after total hip arthroplasty / Range of motion
Time frame: 2 years
Investigators analyze active and passive range of motion (ROM) measured in degrees.
Functional recovery after total hip arthroplasty / Walking speed
Time frame: 2 years
Investigators analyze walking speed in seconds for the 50 meters long walk.
Functional recovery after total hip arthroplasty / Harris Hip Score
Time frame: 2 years
Investigators take a questionnaire (Harris Hip Score, HHS), the maximum point is 100.
Functional recovery after total hip arthroplasty / Hip abductors strength
Time frame: 2 years
Investigators analyze hip abductors strength measured with a dynamometer in kilograms (kg).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
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.
Antea Buterin, MD principal investigator
Clinic OL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional recovery analysis in people with Total Hip Arthroplasty and Functional Recovery, run by Clinic for Orthopedics Lovran at 1 site in Croatia.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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 Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antea Buterin, MD (+385191978453, antea.buterin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional recovery after total hip arthroplasty / Range of motion (time frame: 2 years). The study lists 4 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 21 Nov 2023.