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Recruiting NCT07600632

NCT07600632 Retrospective and Prospective Evaluation of Hip Short Stem Performed by Anterior Approach

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Clinical Trial Summary
NCT ID NCT07600632
Status Recruiting
Phase
Sponsor Istituto Ortopedico Rizzoli
Condition Hip Arthritis
Study Type OBSERVATIONAL
Enrollment 400 participants
Start Date 2025-09-12
Primary Completion 2027-09

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Total Hip Arthroplasty

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 400 participants in total. It began in 2025-09-12 with a primary completion date of 2027-09.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Stefano Lucchini, MD

✉ stefano.lucchini@ior.it

📞 0516366961

Frequently Asked Questions

Who can join the NCT07600632 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Hip Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07600632 currently recruiting?

Yes, NCT07600632 is actively recruiting participants. Contact the research team at stefano.lucchini@ior.it for enrollment information.

Where is the NCT07600632 trial being conducted?

This trial is being conducted at Bologna, Italy.

Who is sponsoring the NCT07600632 clinical trial?

NCT07600632 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 400 participants.

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