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Recruiting NCT07600632

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

— Observational Hip Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total Hip Arthroplasty.
Who it may be relevant to
Registry conditions: Hip Arthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical and Radiographic Evaluation of a Short Stem for Primary Hip Replacement Performed by Anterior Approach: A Retrospective and Prospective Study

Overview

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.

Interventions

  • Procedure Total Hip Arthroplasty
    Total Hip Arthroplasty via Direct Anterior Approach

Primary outcome measures

  • Implants survival [Time frame: at least 5 years after surgery]
Secondary outcome measures (3)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Istituto Ortopedico Rizzoli — Bologna

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. PMID 33427897
  • 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

Identifiers

NCT: NCT07600632 · AMISP 277/2025/Oss/IOR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗