Hip ArthritisAMISPNCT07600632
Retrospective and Prospective Evaluation of Hip Short Stem Performed by Anterior Approach
An observational study of Hip Arthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
This study aims to evaluate the clinical, radiographic, and perioperative outcomes of short femoral stems implanted during primary total hip arthroplasty performed through a minimally invasive direct anterior approach (DAA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthritis
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2025to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population includes consecutively treated adult patients undergoing primary total hip arthroplasty performed through a direct anterior approach with a cementless femoral component, at the Department of Orthopaedics, Trauma Surgery, and Hip and Knee Arthroplasty and Revision Surgery of the IRCCS Istituto Ortopedico Rizzoli. Patients will be included from 2022 (retrospective cohort) to 2027 (prospective cohort).
Who may be able to join
- Diagnosis of primary hip osteoarthritis or osteonecrosis
- Minimally invasive direct anterior approach
- Cementless femoral component
- Minimum follow-up of 2 years
- Patient willingness to participate in the study with written informed consent
- Age over 18 years
- Male or female patients
Who cannot join
- Other diagnoses of secondary hip osteoarthritis
- Non-anterior surgical approach
- Cemented or other types of components
- Patient unwillingness to participate in the study
- Inadequate clinical and radiological documentation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Stefano Lucchini, MD, 0516366961, stefano.lucchini@ior.it
About this study
Official title: Clinical and Radiographic Evaluation of a Short Stem for Primary Hip Replacement Performed by Anterior Approach: A Retrospective and Prospective Study
This study aims to evaluate the clinical, radiographic, and perioperative outcomes of short femoral stems implanted during primary total hip arthroplasty performed through a minimally invasive direct anterior approach (DAA). Short femoral stems have been developed to preserve proximal femoral bone stock, potentially provide a more physiological load transfer, and facilitate implantation through less invasive surgical exposures, particularly in younger and more active patients.
The stem is a cementless hydroxyapatite-coated triple-tapered short stem, has been previously used because its design allows simplified femoral canal preparation and easier implant insertion during minimally invasive anterior approaches, where femoral exposure may be technically demanding. However, previous reports have shown conflicting results regarding implant survivorship and radiographic outcomes, including increased rates of radiolucent lines, pedestal formation, and stem subsidence, particularly among younger and more active patients.
Read more
The present study will investigate the technical and clinical implications of using short femoral stems through a minimally invasive anterior approach. Primary outcomes will include perioperative complication rates, wound characteristics, peri-incisional tissue condition, postoperative bleeding, and other surgery-related complications. Secondary outcomes will include postoperative pain, functional recovery, clinical outcome scores, implant survivorship, and serial radiographic findings at short- and mid-term follow-up.
Given the limited evidence currently available regarding the short- and mid-term performance of short femoral stems implanted through the direct anterior approach, this study aims to provide a comprehensive clinical and radiographic evaluation of these implants over time. Adverse events will be continuously monitored through scheduled clinical and radiographic assessments.
- Conditions
- Hip Arthritis
- Being tested
- Total Hip Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Total Hip Arthroplasty via Direct Anterior Approach
| Study group | Role | What they receive |
|---|---|---|
| patients | Patients undergoing total hip arthroplasty for osteoarthritis through a direct anterior approach with a short femoral stem Receives: Procedure: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implants survival
Survival of hip implants at the follow up period (survival meaning implants which were not revised for any cause at the follow up perios)
Measured: at least 5 years after surgery
Secondary outcomes (3)
Intra and perioperative complications
The Clavien-Dindo score is a system used to classify and standardize postoperative surgical complications according to their severity and the type of treatment required to manage them. It is widely used in clinical studies and surgical registries because it allows objective comparison of outcomes between different techniques or procedures. It was originally proposed by Pierre-Alain Clavien and later modified by Daniel Dindo.
Measured: On the day of the surgery
radiological outcomen 1
osteointegration of the stem according to Le Beguec: Classification of osseointegration according to Emmanuel L. L. Le Béguec: bone ingrowth (stable biological fixation), fibrous fixation (stable but non-osseointegrated interface), and unstable fixation (radiographic and/or clinical signs of loosening).
Measured: at least 5 years after surgery
radiological outcome 2
osteointegration of the stem according to Engh: Classification according to Charles A. Engh: stable bone ingrowth fixation (definitive osseointegration), stable fibrous fixation (no progressive loosening despite absence of full bone ingrowth), and unstable fixation (evidence of implant loosening or migration).
Measured: at least 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start12 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip ArthritisStudies 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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600632
- Sponsor's protocol ID
- AMISP 277/2025/Oss/IOR
- Acronym
- AMISP
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garavaglia G, Gonzalez A, Barea C, Peter R, Hoffmeyer P, Lubbeke A, Hannouche D. Short stem total hip arthroplasty with the direct anterior approach demonstrates suboptimal fixation. Int Orthop. 2021 Mar;45(3):575-583. doi: 10.1007/s00264-020-04910-5. Epub 2021 Jan 11.
PubMed 33427897Giardina F, Castagnini F, Stea S, Bordini B, Montalti M, Toni A. Short Stems Versus Conventional Stems in Cementless Total Hip Arthroplasty: A Long-Term Registry Study. J Arthroplasty. 2018 Jun;33(6):1794-1799. doi: 10.1016/j.arth.2018.01.005. Epub 2018 Jan 11.
PubMed 29395723
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of a Short Stem for Primary Hip Replacement Performed by Anterior Approach: A Retrospective and Prospective Study
- ClinicalTrials.gov ID
- NCT07600632
- Acronym / sponsor ID
- AMISP / AMISP 277/2025/Oss/IOR
- Conditions
- Hip Arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 May 2026 (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 aims to evaluate the clinical, radiographic, and perioperative outcomes of short femoral stems implanted during primary total hip arthroplasty performed through a minimally invasive direct anterior approach (DAA). Short femoral stems have been developed to preserve proximal femoral bone stock, potentially provide a more physiological load transfer, and facilitate implantation through less invasive surgical exposures, particularly in younger and more active patients.
The stem is a cementless hydroxyapatite-coated triple-tapered short stem, has been previously used because its design allows simplified femoral canal preparation and easier implant insertion during minimally invasive anterior approaches, where femoral exposure may be technically demanding. However, previous reports have shown conflicting results regarding implant survivorship and radiographic outcomes, including increased rates of radiolucent lines, pedestal formation, and stem subsidence, particularly among younger and more active patients.
The present study will investigate the technical and clinical implications of using short femoral stems through a minimally invasive anterior approach. Primary outcomes will include perioperative complication rates, wound characteristics, peri-incisional tissue condition, postoperative bleeding, and other surgery-related complications. Secondary outcomes will include postoperative pain, functional recovery, clinical outcome scores, implant survivorship, and serial radiographic findings at short- and mid-term follow-up.
Given the limited evidence currently available regarding the short- and mid-term performance of short femoral stems implanted through the direct anterior approach, this study aims to provide a comprehensive clinical and radiographic evaluation of these implants over time. Adverse events will be continuously monitored through scheduled clinical and radiographic assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Procedure: Total Hip ArthroplastyPatients undergoing total hip arthroplasty for osteoarthritis through a direct anterior approach with a short femoral stem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes consecutively treated adult patients undergoing primary total hip arthroplasty performed through a direct anterior approach with a cementless femoral component, at the Department of Orthopaedics, Trauma Surgery, and Hip and Knee Arthroplasty and Revision Surgery of the IRCCS Istituto Ortopedico Rizzoli. Patients will be included from 2022 (retrospective cohort) to 2027 (prospective cohort).
Key inclusion criteria (7 listed)
- Diagnosis of primary hip osteoarthritis or osteonecrosis
- Minimally invasive direct anterior approach
- Cementless femoral component
- Minimum follow-up of 2 years
- Patient willingness to participate in the study with written informed consent
Key exclusion criteria (5 listed)
- Other diagnoses of secondary hip osteoarthritis
- Non-anterior surgical approach
- Cemented or other types of components
- Patient unwillingness to participate in the study
- Inadequate clinical and radiological documentation
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 |
|---|---|---|
| Total Hip ArthroplastyTotal Hip Arthroplasty via Direct Anterior Approach | Procedure or surgery | patients |
Primary outcome
Implants survival
Time frame: at least 5 years after surgery
Survival of hip implants at the follow up period (survival meaning implants which were not revised for any cause at the follow up perios)
3 secondary outcomes
Intra and perioperative complications
Time frame: On the day of the surgery
radiological outcomen 1
Time frame: at least 5 years after surgery
radiological outcome 2
Time frame: at least 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Results publication: PubMed 33427897Garavaglia G, Gonzalez A, Barea C, Peter R, Hoffmeyer P, Lubbeke A, Hannouche D. Short stem total hip arthroplasty with the direct anterior approach demonstrates suboptimal fixation. Int Orthop. 2021 Mar;45(3):575-583. doi: 10.1007/s00264-020-04910-5. Epub 2021 Jan 11.
- Results publication: PubMed 29395723Giardina F, Castagnini F, Stea S, Bordini B, Montalti M, Toni A. Short Stems Versus Conventional Stems in Cementless Total Hip Arthroplasty: A Long-Term Registry Study. J Arthroplasty. 2018 Jun;33(6):1794-1799. doi: 10.1016/j.arth.2018.01.005. Epub 2018 Jan 11.
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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.
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 Hip Arthritis, 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 7 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: looking for participants now, as of the sponsor's last update on 20 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Lucchini, MD (0516366961, stefano.lucchini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implants survival (time frame: at least 5 years after surgery). 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 NCT07600632, which also lists 2 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 20 May 2026.