About this trial
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
This trial does not accept healthy volunteersQualifiers
Diagnosis of primary hip osteoarthritis or osteonecrosis
Minimally invasive direct anterior approach
Cementless femoral component
Minimum follow-up of 2 years
Disqualifiers
Other diagnoses of secondary hip osteoarthritis
Non-anterior surgical approach
Cemented or other types of components
Patient unwillingness to participate in the study
Trial 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).
Trial design
Cohort
Prospective
Treatments tested in this trial
Total Hip Arthroplasty
Procedure/SurgeryTotal Hip Arthroplasty via Direct Anterior Approach
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Intra and perioperative complications
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.
radiological outcomen 1
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).
radiological outcome 2
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).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.