Patient ComplianceTHRNCT04243980
Anatomical Femoral Stem in Total Hip Arthroplasty
An observational study of Patient Compliance and Patient Satisfaction, run by HaEmek Medical Center, Israel.
Trial summary
A study that detect the femoral anteversion after total hip arthroplasty using short anatomical femoral stem compared to the contrast side Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patient Compliance, Patient Satisfaction
- What is being tested?
- Short anatomical femoral stem in THR
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Jan 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients aged 18 - 90 who had THR as an elective surgery
Who may be able to join
- age 18-90
- patients who had THR as an elective surgery
- patients who had THR with short femoral anatomical stem
Who cannot join
- severe osteoporosis with Dorr C classification
- s/p bilateral hip arthroplasty
- non-complaint patients
- revision surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Short Term Results of Short Anatomical Femoral Stem in Total Hip Arthroplasty - Prospective Study
A study that detect the femoral anteversion after total hip arthroplasty using short anatomical femoral stem compared to the contrast side
- Conditions
- Patient Compliance, Patient Satisfaction
- Being tested
- Short anatomical femoral stem in THR
- Medical subject headings
- Patient Compliance, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short anatomical femoral stem in THRDevice
Patients with osteoarthritis after total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients after total hip arthroplasty with short femoral stem Receives: Device: Short anatomical femoral stem in THR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral anteversion
comparing femoral anteversion after THR using CT scan
Measured: Post-Operatively, through study completion, an average of 2 years
Secondary outcomes (1)
Harris Hip Score
The HHS is a physician-completed instrument that consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 0-4 points), and range of motion (2 items, 0-5 points).
Where a score < 70 indicating a poor result and those of 90-100 indicating an excellent result
Measured: 6 weeks, 3 month, 6 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raja Hakim, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243980
- Sponsor's protocol ID
- EMC-19-0100
- Acronym
- THR
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2020
- Last updated
- 28 Jan 2020
- 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 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Results of Short Anatomical Femoral Stem in Total Hip Arthroplasty - Prospective Study
- ClinicalTrials.gov ID
- NCT04243980
- Acronym / sponsor ID
- THR / EMC-19-0100
- Conditions
- Patient Compliance, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 28 Jan 2020 (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.
A study that detect the femoral anteversion after total hip arthroplasty using short anatomical femoral stem compared to the contrast side
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Short anatomical femoral stem in THRPatients after total hip arthroplasty with short femoral stem |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged 18 - 90 who had THR as an elective surgery
Key inclusion criteria (3 listed)
- age 18-90
- patients who had THR as an elective surgery
- patients who had THR with short femoral anatomical stem
Key exclusion criteria (4 listed)
- severe osteoporosis with Dorr C classification
- s/p bilateral hip arthroplasty
- non-complaint patients
- revision surgery
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 |
|---|---|---|
| Short anatomical femoral stem in THRPatients with osteoarthritis after total hip arthroplasty | Device | Group 1 |
Primary outcome
Femoral anteversion
Time frame: Post-Operatively, through study completion, an average of 2 years
comparing femoral anteversion after THR using CT scan
1 secondary outcome
Harris Hip Score
Time frame: 6 weeks, 3 month, 6 month post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Compliance and Patient Satisfaction, run by HaEmek Medical Center, Israel.
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 3 inclusion and 4 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 28 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja Hakim, M.D. (00972546612251, raja.hakim@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral anteversion (time frame: Post-Operatively, through study completion, an average of 2 years). 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 28 Jan 2020.