Aseptic; OsteonecrosisTHANCT05666284
Radiographic Changes and Clinical Implications of Implantation of Shortened Uncemented Femoral Stems in THA
An observational study of Aseptic; Osteonecrosis and Hip Osteoarthritis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The hip prosthesis market is constantly growing with the number of prostheses reaching 949,000 in 2019. Along with this, there is also an increase in interest in short stems also called shortened stems. Thus on Pubmed, in 5 years, 171 publications have been listed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aseptic; Osteonecrosis, Hip Osteoarthritis
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2022to 31 Dec 2023
- 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
- Adult, Older adult
Study population: Adult patient operated for first-line THA for an indication of centric hip osteoarthritis (including minor dysplasia and coxa profunda) and aseptic osteonecrosis of the femoral head
Who may be able to join
- Male or female (age ≥18 years old)
- Subject operated for first-line THA for an indication of centric hip osteoarthritis (including minor dysplasia and coxa profunda) and aseptic osteonecrosis of the femoral head
- Subject who received a THA between January 2015 and December 2019
- Subject who received an uncemented shortened SCC or SCLA femoral stem
- Radiological data available: pre-operative, immediate post-operative and post-operative at a minimum of 2 years (≥24 months)
- Subject not objecting to the reuse of their data for scientific research purposes.
Who cannot join
- Subject having expressed its opposition to the reuse of its data for scientific research purposes.
- Patient operated for inflammatory pathology or major dysplasia, recovery
- Associated fractures or sequelae of fractures
- Patient having presented intraoperative or early complications such as infections, intraoperative fracture, dislocation of the hip following the installation of the THA
- Revision of hip arthroplasty during the study follow-up period for a cause not studied in the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Orthopédique et de Traumatologie du Membre Inférieur - CHU de Strasbourg - France
Strasbourg, 67091
François BONNOMET, MD, PhD, 33 3 68 76 52 82, Francois.bonnomet@chru-strasbourg.fr
François BONNOMET, MD, PhD
About this study
Official title: Study of Radiographic Changes and Their Clinical Implications at 2 Years of Implantation of Shortened Uncemented Femoral Stems in Total Hip Arthroplasty
The hip prosthesis market is constantly growing with the number of prostheses reaching 949,000 in 2019. Along with this, there is also an increase in interest in short stems also called shortened stems. Thus on Pubmed, in 5 years, 171 publications have been listed.
Thus, it seems interesting to study and analyze the performance of the shortened stem used in the Department of Orthopedic Surgery and Traumatology of the University Hospitals of Strasbourg and to compare them with the results of the literature.
Read the detailed description
The objective of this study is to observe the appearance of shortened stem radiological abnormalities at least 2 years postoperatively.
- Conditions
- Aseptic; Osteonecrosis, Hip Osteoarthritis
- Keywords
- Hip Osteoarthritis, Aseptic; Osteonecrosis, Coxarthrosis, Avascular Necrosis of the Femoral Head
- Medical subject headings
- Infertility, Osteonecrosis, Osteoarthritis, Hip, Femur Head Necrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone changes around the femoral implant at 2 years on hip radiographs.
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start11 Oct 2022
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aseptic; OsteonecrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666284
- Sponsor's protocol ID
- 8720
- Acronym
- THA
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Radiographic Changes and Their Clinical Implications at 2 Years of Implantation of Shortened Uncemented Femoral Stems in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05666284
- Acronym / sponsor ID
- THA / 8720
- Conditions
- Aseptic; Osteonecrosis, Hip Osteoarthritis
- Keywords
- Hip Osteoarthritis, Aseptic; Osteonecrosis, Coxarthrosis, Avascular Necrosis of the Femoral Head
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Dec 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.
The hip prosthesis market is constantly growing with the number of prostheses reaching 949,000 in 2019. Along with this, there is also an increase in interest in short stems also called shortened stems. Thus on Pubmed, in 5 years, 171 publications have been listed.
Thus, it seems interesting to study and analyze the performance of the shortened stem used in the Department of Orthopedic Surgery and Traumatology of the University Hospitals of Strasbourg and to compare them with the results of the literature.
Detailed description
The objective of this study is to observe the appearance of shortened stem radiological abnormalities at least 2 years postoperatively.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient operated for first-line THA for an indication of centric hip osteoarthritis (including minor dysplasia and coxa profunda) and aseptic osteonecrosis of the femoral head
Key inclusion criteria (6 listed)
- Male or female (age ≥18 years old)
- Subject operated for first-line THA for an indication of centric hip osteoarthritis (including minor dysplasia and coxa profunda) and aseptic osteonecrosis of the femoral head
- Subject who received a THA between January 2015 and December 2019
- Subject who received an uncemented shortened SCC or SCLA femoral stem
- Radiological data available: pre-operative, immediate post-operative and post-operative at a minimum of 2 years (≥24 months)
Key exclusion criteria (5 listed)
- Subject having expressed its opposition to the reuse of its data for scientific research purposes.
- Patient operated for inflammatory pathology or major dysplasia, recovery
- Associated fractures or sequelae of fractures
- Patient having presented intraoperative or early complications such as infections, intraoperative fracture, dislocation of the hip following the installation of the THA
- Revision of hip arthroplasty during the study follow-up period for a cause not studied in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone changes around the femoral implant at 2 years on hip radiographs.
Time frame: 2 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
Related trials for Aseptic; Osteonecrosis
Recruiting
Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
Osteonecrosis of the Femoral Head, Avascular Necrosis of the Femoral Head
Active, not recruiting
Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
Osteoarthritis, Hip, Coxarthrosis; Primary
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.
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 Aseptic; Osteonecrosis and Hip Osteoarthritis, run by University Hospital, Strasbourg, France at 1 site in France.
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 6 inclusion and 5 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 19 Dec 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 France. 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 François BONNOMET, MD, PhD (33 3 68 76 52 82, Francois.bonnomet@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone changes around the femoral implant at 2 years on hip radiographs. (time frame: 2 years postoperatively). 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 19 Dec 2023.