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NCT Number: NCT07600632

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Stefano Lucchini, MD

CONTACT

[email protected]

0516366961

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Hip Arthroplasty

Procedure

Total Hip Arthroplasty via Direct Anterior Approach

Primary outcomes

  1. 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)

Secondary outcomes

  1. Intra and perioperative complications

    Time frame: On the day of the surgery

    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.

  2. radiological outcomen 1

    Time frame: at least 5 years after surgery

    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).

  3. radiological outcome 2

    Time frame: at least 5 years after surgery

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Lucchini, MD

CONTACT

[email protected]

0516366961

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: AMISP

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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