IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
Location status: Recruiting
NCT Number: NCT07600632
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bologna, 40136, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total Hip Arthroplasty via Direct Anterior Approach
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)
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.
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).
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).
Contact information is provided by the study sponsor or research team.
Istituto Ortopedico Rizzoli
Other
Clinical and Radiographic Evaluation of a Short Stem for Primary Hip Replacement Performed by Anterior Approach: A Retrospective and Prospective Study
Acronym: AMISP
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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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