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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07600632
Acronym
AMISP
Enrollment
400
Registered
2026-05-20
Start date
2025-09-12
Completion date
2030-12-01
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthritis

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.

Interventions

PROCEDURETotal Hip Arthroplasty

Total Hip Arthroplasty via Direct Anterior Approach

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Implants survivalat least 5 years after surgerySurvival of hip implants at the follow up period (survival meaning implants which were not revised for any cause at the follow up perios)

Secondary

MeasureTime frameDescription
Intra and perioperative complicationsOn the day of the surgeryThe 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.
radiological outcomen 1at least 5 years after surgeryosteointegration 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).
radiological outcome 2at least 5 years after surgeryosteointegration 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).

Countries

Italy

Contacts

CONTACTStefano Lucchini, MD
stefano.lucchini@ior.it0516366961

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026