Total HipTHRNCT06173557
Intraoperative Measurement Technique
An observational study of Total Hip and Limb Length Discrepancy, run by Ziv Medical Center.
Trial summary
This retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Hip, Limb Length Discrepancy
- What is being tested?
- entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic i
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2015to 20 Jun 2017
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 50 consecutive patients who were admitted to the orthopedic department for elective THR
Who may be able to join
- patients that underwent THR due to primary osteoarthritis of the hip joint.
Who cannot join
- Patients who underwent THR for any other reasons
- patients that underwent revision surgery
About this study
Official title: Intraoperative Measurement Technique for Improved Accuracy of Femoral Offset and Leg Length in Total Hip Replacement: A Retrospective Cohort Study
This retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports.
Read the detailed description
Introduction: Restoration of limb length equality and femoral offset is critical for the success of THR. The purpose of this study was to investigate the efficacy of a novel intraoperative measurement technique in minimizing errors in leg length and offset in total hip replacement (THR).
Methods: This retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports.
- Conditions
- Total Hip, Limb Length Discrepancy
- Being tested
- entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic i
- Keywords
- total hip replacement, limb length discrepancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic iProcedure or surgery
technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome
calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start23 Mar 2015
- Primary completion20 Mar 2017
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total HipStudies 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 only
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ziv Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Rothem, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173557
- Sponsor's protocol ID
- ZivMC
- Other IDs
- 0025-15-ziv
- Acronym
- THR
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Measurement Technique for Improved Accuracy of Femoral Offset and Leg Length in Total Hip Replacement: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06173557
- Acronym / sponsor ID
- THR / ZivMC
- Conditions
- Total Hip, Limb Length Discrepancy
- Keywords
- total hip replacement, limb length discrepancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ziv Medical CenterUniversity, hospital or other
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 15 Dec 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 retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports.
Detailed description
Introduction: Restoration of limb length equality and femoral offset is critical for the success of THR. The purpose of this study was to investigate the efficacy of a novel intraoperative measurement technique in minimizing errors in leg length and offset in total hip replacement (THR).
Methods: This retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 50 consecutive patients who were admitted to the orthopedic department for elective THR
Key inclusion criteria (1 listed)
- patients that underwent THR due to primary osteoarthritis of the hip joint.
Key exclusion criteria (2 listed)
- Patients who underwent THR for any other reasons
- patients that underwent 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 |
|---|---|---|
| entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic itechnique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports | Procedure or surgery | – |
Primary outcome
outcome
Time frame: 1 year
calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver
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 15 Dec 2023.
- Individual participant dataSharing planned: No. no sharing
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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 Total Hip and Limb Length Discrepancy, run by Ziv Medical Center.
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 2 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 15 Dec 2023. 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?
outcome (time frame: 1 year). 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 15 Dec 2023.