RecruitingNot Applicable

Retrospective and Prospective Evaluation of Hip Short Stem Performed by Anterior Approach

Italy400 participantsStarted 2025-09-12

Plain-language 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). 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is studying how well a short-stem hip implant holds up over time when placed through the anterior approach — how does that surgical technique and implant design compare to what you would use for my hip arthritis, and why might one be better suited for my situation?
2Since this study is collecting data both retrospectively and prospectively, meaning some results come from patients already treated and some from new patients going forward, how does that affect what I might learn about my own outcomes if I participate?
3The main thing being measured is how long the implant survives without failing — based on what's known so far about short-stem implants placed through the anterior approach, what does the current evidence suggest about durability compared to standard hip replacement options?
4This trial is listed as 'Phase NA,' which often means it's observational rather than testing a new treatment — does participating actually change the care I receive, or would I simply be followed and monitored using the same procedure I might get anyway?
5Given that this study is still recruiting, are there alternative surgical approaches or implant types already supported by longer-term data that I should consider before deciding whether joining this study makes sense for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Implants survival

Timeframe: at least 5 years after surgery

Trial details

NCT IDNCT07600632

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09

Contact for this trial

Stefano Lucchini, MD

0516366961 stefano.lucchini@ior.it

View on ClinicalTrials.gov More Hip Arthritis trials