Dysplasia; HipRetroConeNCT04748458
Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies
An observational study of Dysplasia; Hip and Prosthesis Survival, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysplasia; Hip, Prosthesis Survival
- What is being tested?
- Conical tapered stem
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jul 2020to 2 Oct 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: retrospective, consecutive adult population treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies.
Who may be able to join
- Symptomatic hip osteoarthritis due to congenital hip pathologies
- Consecutive population with a minimum follow-up of 2 years
- Cementless total hip arthroplasty with conical tapered stem
- Pre-operative planning using CT
- Complete clinical and radiographic assessment
Who cannot join
- Other type of hip osteoarthritis
- Other type of implants
- Inadequate pre-operative planning (eg: no CT)
- Incomplete clinical and radiographic assessment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
Bologna, 40136
About this study
Official title: Retrospective Study About the Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty for Osteoarthritis Due to Congenital Hip Pathologies
A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant and the survival rates in such a specific cohort.
Read the detailed description
Congenital hip pathologies may severely alter the local anatomy of the hip, making total hip arthroplasty (THA) due to osteoarthritis after congenital hip pathologies challenging. While it seems that congenital hip pathologies did not significantly influence the outcomes when compared to THA after osteoarthritis, the choice of implant was demonstrated to impact the survival rates of the THA after congenital hip pathologies.
To date, no guidelines exist about the correct choice of hip implant in congenital hip pathologies: only mid-term case series are available. Conical tapered stems have been frequently suggested for the most difficult cases.
The aim of this study is to describe the survival rates and the long-term clinical and radiological outcome of conical tapered stems in THAs after congenital hip pathologies.
- Conditions
- Dysplasia; Hip, Prosthesis Survival
- Being tested
- Conical tapered stem
- Medical subject headings
- Hip Dislocation, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conical tapered stemDevice
Implantation of conical tapered stem
| Study group | Role | What they receive |
|---|---|---|
| Congenital hip pathologies | Conical tapered stem for osteoarthritis due to congenital hip pathologies Receives: Device: Conical tapered stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.
Measured: 15 months
Survival Rate
Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.
Measured: 15 months
Radiographic Cup Osseointegration
Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines).
Measured: 15 months
Radiographic Stem Osseointegration
Osseointegrated stems described according to Engh's criteria
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start17 Jul 2020
- Primary completion1 Oct 2021
- Study completion2 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dysplasia; HipStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Traina, Prof, Study director, IRCCS Istituto Ortopedico Rizzoli, Bologna, ITaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748458
- Sponsor's protocol ID
- 589/2020/Oss/IOR
- Acronym
- RetroCone
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 22 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greber EM, Pelt CE, Gililland JM, Anderson MB, Erickson JA, Peters CL. Challenges in Total Hip Arthroplasty in the Setting of Developmental Dysplasia of the Hip. J Arthroplasty. 2017 Sep;32(9S):S38-S44. doi: 10.1016/j.arth.2017.02.024. Epub 2017 Feb 22.
PubMed 28291651Perry KI, Berry DJ. Femoral considerations for total hip replacement in hip dysplasia. Orthop Clin North Am. 2012 Jul;43(3):377-86. doi: 10.1016/j.ocl.2012.05.010.
PubMed 22819165Argenson JN, Flecher X, Parratte S, Aubaniac JM. Anatomy of the dysplastic hip and consequences for total hip arthroplasty. Clin Orthop Relat Res. 2007 Dec;465:40-5. doi: 10.1097/BLO.0b013e3181576052.
PubMed 17906591Pak P, de Steiger R. Cone femoral prosthesis for osteoarthritis of the hip with femoral dysplasia. J Orthop Surg (Hong Kong). 2008 Aug;16(2):206-10. doi: 10.1177/230949900801600216.
PubMed 18725674Taniguchi N, Jinno T, Koga D, Hagino T, Okawa A, Haro H. Cementless Hip Stem Anteversion in the Dysplastic Hip: A Comparison of Tapered Wedge vs Metaphyseal Filling. J Arthroplasty. 2017 May;32(5):1547-1552. doi: 10.1016/j.arth.2016.12.020. Epub 2016 Dec 22.
PubMed 28110848
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study About the Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty for Osteoarthritis Due to Congenital Hip Pathologies
- ClinicalTrials.gov ID
- NCT04748458
- Acronym / sponsor ID
- RetroCone / 589/2020/Oss/IOR
- Conditions
- Dysplasia; Hip, Prosthesis Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 2 Oct 2021 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Posted 22 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant and the survival rates in such a specific cohort.
Detailed description
Congenital hip pathologies may severely alter the local anatomy of the hip, making total hip arthroplasty (THA) due to osteoarthritis after congenital hip pathologies challenging. While it seems that congenital hip pathologies did not significantly influence the outcomes when compared to THA after osteoarthritis, the choice of implant was demonstrated to impact the survival rates of the THA after congenital hip pathologies.
To date, no guidelines exist about the correct choice of hip implant in congenital hip pathologies: only mid-term case series are available. Conical tapered stems have been frequently suggested for the most difficult cases.
The aim of this study is to describe the survival rates and the long-term clinical and radiological outcome of conical tapered stems in THAs after congenital hip pathologies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congenital hip pathologies | – | Device: Conical tapered stemConical tapered stem for osteoarthritis due to congenital hip pathologies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- retrospective, consecutive adult population treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies.
Key inclusion criteria (5 listed)
- Symptomatic hip osteoarthritis due to congenital hip pathologies
- Consecutive population with a minimum follow-up of 2 years
- Cementless total hip arthroplasty with conical tapered stem
- Pre-operative planning using CT
- Complete clinical and radiographic assessment
Key exclusion criteria (4 listed)
- Other type of hip osteoarthritis
- Other type of implants
- Inadequate pre-operative planning (eg: no CT)
- Incomplete clinical and radiographic assessment
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 |
|---|---|---|
| Conical tapered stemImplantation of conical tapered stem | Device | Congenital hip pathologies |
Primary outcome
Harris Hip Score
Time frame: 15 months
Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.
Survival Rate
Time frame: 15 months
Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.
Radiographic Cup Osseointegration
Time frame: 15 months
Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines).
Radiographic Stem Osseointegration
Time frame: 15 months
Osseointegrated stems described according to Engh's criteria
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28291651Greber EM, Pelt CE, Gililland JM, Anderson MB, Erickson JA, Peters CL. Challenges in Total Hip Arthroplasty in the Setting of Developmental Dysplasia of the Hip. J Arthroplasty. 2017 Sep;32(9S):S38-S44. doi: 10.1016/j.arth.2017.02.024. Epub 2017 Feb 22.
- Results publication: PubMed 22819165Perry KI, Berry DJ. Femoral considerations for total hip replacement in hip dysplasia. Orthop Clin North Am. 2012 Jul;43(3):377-86. doi: 10.1016/j.ocl.2012.05.010.
- Results publication: PubMed 17906591Argenson JN, Flecher X, Parratte S, Aubaniac JM. Anatomy of the dysplastic hip and consequences for total hip arthroplasty. Clin Orthop Relat Res. 2007 Dec;465:40-5. doi: 10.1097/BLO.0b013e3181576052.
- Results publication: PubMed 18725674Pak P, de Steiger R. Cone femoral prosthesis for osteoarthritis of the hip with femoral dysplasia. J Orthop Surg (Hong Kong). 2008 Aug;16(2):206-10. doi: 10.1177/230949900801600216.
- Results publication: PubMed 28110848Taniguchi N, Jinno T, Koga D, Hagino T, Okawa A, Haro H. Cementless Hip Stem Anteversion in the Dysplastic Hip: A Comparison of Tapered Wedge vs Metaphyseal Filling. J Arthroplasty. 2017 May;32(5):1547-1552. doi: 10.1016/j.arth.2016.12.020. Epub 2016 Dec 22.
- 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.
Francesco Traina, Prof study director
IRCCS Istituto Ortopedico Rizzoli, Bologna, ITaly
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 Dysplasia; Hip and Prosthesis Survival, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 5 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: finished, as of the sponsor's last update on 22 Mar 2022. 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 Italy. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Harris Hip Score (time frame: 15 months). 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?
On the ClinicalTrials.gov record for NCT04748458, which also lists 5 linked publications.
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 22 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.