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

NCT07600632 | Recruiting

• 1 other identifier: AMISP 277/2025/Oss/IOR
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthritis

Outcome Measures

Primary Outcomes (1)

• 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)

  at least 5 years after surgery

Secondary Outcomes (3)

• Intra and perioperative complications

  On the day of the surgery

• radiological outcomen 1

  at least 5 years after surgery

• radiological outcome 2

  at least 5 years after surgery

Study Arms (1)

patients

Patients undergoing total hip arthroplasty for osteoarthritis through a direct anterior approach with a short femoral stem

Procedure: Total Hip Arthroplasty

Interventions

Total Hip Arthroplasty PROCEDURE

Total Hip Arthroplasty via Direct Anterior Approach

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 33427897 RESULT

• Giardina 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.

  PMID: 29395723 RESULT

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Stefano Lucchini, MD

CONTACT

0516366961; stefano.lucchini@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start: September 12, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

IT (1)