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The clinical efficacy of Medial Sustain Nail(MSN) and Proximal femoral nail anti-rotation(PFNA) for fixation of medial comminuted trochanteric fractures: a prospective randomized controlled trial

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Abstract

Purpos

To evaluate the clinical efficacy of the Medial Sustain Nail (MSN) for medial comminuted trochanteric fractures fixation in comparison to Proximal Femoral Nail Antirotation (PFNA) through a clinical study.

Methods

A non-inferiority randomized controlled trial was conducted at a single centre between July 2019 and July 2020. Fifty patients diagnosed comminuted trochanteric fractures were randomly assigned to either the MSN group (n = 25) or the PFNA group (n = 25). A total of forty-three patients were included in the final study analysis. The primary outcome measure was Short Form 36 health surgery physical component summary (SF-36 PCS) score. Secondary outcomes included the Oxford Hip Scores (OHS), weight bearing, complication relate to implant and so on. This study was not blined to surgeons, but to patients and data analysts.

Results

The MSN demonstrated significantly better functional outcomes as measured by SF-36 PCS and OHS at six months postoperative compared to PFNA (p < 0.05). Union of fractures in the MSN group reached 90.9% at three months after surgery, whereas the PFNA group achieved a union rate of 57.1% (p < 0.05). Furthermore, weight-bearing time of MSN group was earlier than PFNA group (p < 0.05). Additionally, complications related to implant usage were more prevalent in the PFNA group (33.3%) compared to the MSN group (4.5%) (p < 0.05).

Conclusion

MSN exhibited superior quality of life outcomes compared to PFNA at six months postoperative. This indicates that MSN effectively reconstructs medial femoral support in patients with comminuted trochanteric fractures, which facilitates early weight-bearing and accelerates the recovery process.

Trial registration: Trial registration number: NCT01437176, Date of the trial registration:2011–9-1, Date of commencement of the study:2011–9, Date of enrolment/recruitment of the study subjects:2019–7.

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Acknowledgements

The authors would like to thank WEIGAO ORTHOPAEDIC corporation for the MSN provided.

Funding

This work was supported by the Youth Independent Innovation Science Foundation of PLA General Hospital (22QNCZ044).

Author information

Author notes

  1. Shaobo Nie, Jiantao Li and Xiao Liu contributed equally to this work.

Authors and Affiliations

  1. Department of Orthopaedics, The First Medical Centre of Chinese PLA General Hospital, Beijing, 100853, China

    Shaobo Nie & Xiaoyong Wu

  2. National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation, Beijing, 100853, China

    Shaobo Nie, Jiantao Li, Xiao Liu, Jianheng Liu, Xiaoyong Wu, Peifu Tang, Yanpeng Zhao, Ming Li & Licheng Zhang

  3. Senior Department of Orthopaedics, The Fourth Medical Center of Chinese, PLA General Hospital, Beijing, 100853, China

    Jiantao Li, Xiao Liu, Jianheng Liu, Peifu Tang, Yanpeng Zhao, Ming Li & Licheng Zhang

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Contributions

Shaobo Nie: Designed the study, performed the experiments, collected, analyzed, and interpreted the data, drafted and revised the manuscript.

Jiantao Li: Performed the experiments, collected, analyzed, and interpreted the data, revised the manuscript.

Xiao Liu: Performed the experiments, collected, analyzed, and interpreted the data, revised the manuscript.

Jianheng Liu: collected and analyzed the data, read and approved the final manuscript.

Xiaoyong Wu: collected and analyzed the data, read and approved the final manuscript.

Peifu Tang: Designed the study, revised the manuscript.

Yanpeng Zhao: Designed the study, revised the manuscript.

Ming Li: Performed the experiments, designed the study, drafted and revised the manuscript.

Licheng Zhang: Designed the study, revised the manuscript.

Corresponding authors

Correspondence to Yanpeng Zhao, Ming Li or Licheng Zhang.

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Ethical review statement

This study was approved by Chinese PLA general hospital ethical review boards (S2019-089–02).

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Nie, S., Li, J., Liu, X. et al. The clinical efficacy of Medial Sustain Nail(MSN) and Proximal femoral nail anti-rotation(PFNA) for fixation of medial comminuted trochanteric fractures: a prospective randomized controlled trial. International Orthopaedics (SICOT) (2024). https://doi.org/10.1007/s00264-024-06220-6

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