Mid-Term Clinical, Radiographic, and Safety Outcomes After Hemiarthroplasty with the CL TRAUMA Cemented Femoral Stem: A Post-Market Clinical Investigation
- 1Orthopedics and Orthopedic Oncology, Department of Surgery, Oncology and Gastroenterology, University-Hospital of Padova, 35128 Padova, Italy
- 2Centre for Mechanics of Biological Materials, University of Padova, 35131 Padova, Italy
- 3Musculoskeletal Pathology and Oncology Laboratory, Department of Surgery, Oncology and Gastroenterology, University of Padova, 35128 Padova, Italy
Abstract
Background/Objectives: Cemented femoral stems are a well-established treatment option for femoral neck fractures (FNFs) in elderly patients. This study evaluated mid-term clinical and radiographic outcomes and safety profile in patients undergoing hemiarthroplasty with the CL TRAUMA cemented femoral stem (LimaCorporate) for FNF. Methods: The single-center observational Post-Market Clinical Investigation identified 474 patients who underwent hip arthroplasty between 2017 and 2023. Of these, 54 (11.4%) who were alive, contactable, willing, and physically able to attend were included in the mid-term follow-up (FU) assessment. Perioperative, discharge, and 1-month FU data were collected retrospectively, while mid-term clinical and radiographic FU was performed prospectively after a minimum of 2 years. The primary endpoint was satisfactory status, defined as a Harris Hip Score (HHS) ≥ 80. Secondary endpoints included patient satisfaction assessed using Visual Analogue Scale (VAS), radiographic outcomes, and documented serious adverse events (SAEs). Results: The 54 evaluated patients (54/474; 11.4% of the implanted population) included 49 females and 5 males, with a mean age at surgery of 77.1 ± 9.1 years and a mean FU of 4.4 ± 0.8 years. All patients underwent hemiarthroplasty for FNF. Mean HHS was 80.6 ± 16.9, with 33 patients (61.1%) achieving the primary endpoint. Mean VAS satisfaction was 76.4 ± 29.3. At mid-term FU, RLLs were observed in 38.9% of patients, predominantly of limited thickness. Distal stem migration was observed in one case (1.9%), and bone remodeling in three patients (5.6%). Eleven SAEs occurred in 10 patients (18.5%); three events were related and two possibly related to the surgical procedure, whereas none was considered related to the device. No femoral stem revisions were documented among the 54 evaluated patients during the available FU. Conclusions: Among the selected patients who survived and completed mid-term follow-up after bipolar hemiarthroplasty with the CL TRAUMA cemented femoral stem, satisfactory functional status and patient satisfaction were observed, together with generally stable stem-specific radiographic findings. No SAEs were considered related to the femoral stem, and no femoral stem revisions were documented. These findings should be interpreted cautiously and cannot be extrapolated to the entire implanted population.
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BibTeX
@article{biz2026midterm,
title = {{Mid-Term Clinical, Radiographic, and Safety Outcomes After Hemiarthroplasty with the CL TRAUMA Cemented Femoral Stem: A Post-Market Clinical Investigation}},
author = {Carlo Biz and Assunta Pozzuoli and Giacomo Maso and Elisa Belluzzi and Pietro Ruggieri},
journal = {Journal of Clinical Medicine},
year = {2026},
month = nov,
doi = {10.3390/jcm15218640},
url = {https://www.mdpi.com/2077-0383/15/21/8640},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Mid-Term Clinical, Radiographic, and Safety Outcomes After Hemiarthroplasty with the CL TRAUMA Cemented Femoral Stem: A Post-Market Clinical Investigation
AU - Carlo Biz
AU - Assunta Pozzuoli
AU - Giacomo Maso
AU - Elisa Belluzzi
AU - Pietro Ruggieri
PY - 2026
DA - 2026/11/06
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15218640
UR - https://www.mdpi.com/2077-0383/15/21/8640
AB - Background/Objectives: Cemented femoral stems are a well-established treatment option for femoral neck fractures (FNFs) in elderly patients. This study evaluated mid-term clinical and radiographic outcomes and safety profile in patients undergoing hemiarthroplasty with the CL TRAUMA cemented femoral stem (LimaCorporate) for FNF. Methods: The single-center observational Post-Market Clinical Investigation identified 474 patients who underwent hip arthroplasty between 2017 and 2023. Of these, 54 (11.4%) who were alive, contactable, willing, and physically able to attend were included in the mid-term follow-up (FU) assessment. Perioperative, discharge, and 1-month FU data were collected retrospectively, while mid-term clinical and radiographic FU was performed prospectively after a minimum of 2 years. The primary endpoint was satisfactory status, defined as a Harris Hip Score (HHS) ≥ 80. Secondary endpoints included patient satisfaction assessed using Visual Analogue Scale (VAS), radiographic outcomes, and documented serious adverse events (SAEs). Results: The 54 evaluated patients (54/474; 11.4% of the implanted population) included 49 females and 5 males, with a mean age at surgery of 77.1 ± 9.1 years and a mean FU of 4.4 ± 0.8 years. All patients underwent hemiarthroplasty for FNF. Mean HHS was 80.6 ± 16.9, with 33 patients (61.1%) achieving the primary endpoint. Mean VAS satisfaction was 76.4 ± 29.3. At mid-term FU, RLLs were observed in 38.9% of patients, predominantly of limited thickness. Distal stem migration was observed in one case (1.9%), and bone remodeling in three patients (5.6%). Eleven SAEs occurred in 10 patients (18.5%); three events were related and two possibly related to the surgical procedure, whereas none was considered related to the device. No femoral stem revisions were documented among the 54 evaluated patients during the available FU. Conclusions: Among the selected patients who survived and completed mid-term follow-up after bipolar hemiarthroplasty with the CL TRAUMA cemented femoral stem, satisfactory functional status and patient satisfaction were observed, together with generally stable stem-specific radiographic findings. No SAEs were considered related to the femoral stem, and no femoral stem revisions were documented. These findings should be interpreted cautiously and cannot be extrapolated to the entire implanted population.
SN - 2077-0383
ER -