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.

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.