The aim of our RCT was to evaluate safety and efficacy of a new device called Prevention Nail System (PNS) developed for the prevention of femoral neck fractures (FNFs) in patients with severe osteoporosis. The PNS is a titanium screw with a hydroxyapatite coating implanted in the femoral neck in order to reinforce it. We enrolled patients with: FNF; age ≥65 years; DXA of the noninjured hip with a T-score ≤ −2.5 SD. In the fractured hip patients received standard treatment while the contralateral hip was randomized either to receive PNS (group A) or not: control group (B). During each follow-up (FU) at 3, 12 and 24 months, DXA, CT and X-rays of the reinforced hip were performed.
The mean age was 83 years and the preoperative DXA was −3.3 SD in both groups. The walking ability of patients with PNS were comparable to controls. The CT scan showed good integration of the PNS in the bone. At the longest available FU 23 patients reported one or more falls. 16 nonfemoral fractures were recorded: 10 (A) and 6 (B) and 6 contralateral hip fractures (CHFs): 3 in the PNS group and 3 in the control group. In A all CHFs occurred within 1 month after surgery and there was a difficult screw placement during surgery, in the control group the CHFs were consequence of a fall (6 months to 2 years after the first FNF). No statistical differences were reported between groups A and B.
In conclusion, the device was well tolerated; CHFs in the PNS group should be considered a technical error due to the surgical instruments. Safety of the device can be increased by improving the instruments to reduce the risk of iatrogenic fractures.
| Identifer | oai:union.ndltd.org:unibo.it/oai:amsdottorato.cib.unibo.it:7302 |
| Date | January 1900 |
| Creators | Chiarello, Eugenio <1981> |
| Contributors | Buda, Roberto Emanuele Cesare |
| Publisher | Alma Mater Studiorum - Università di Bologna |
| Source Sets | Università di Bologna |
| Language | English |
| Detected Language | English |
| Type | Doctoral Thesis, PeerReviewed |
| Format | application/pdf |
| Rights | info:eu-repo/semantics/embargoedAccess |
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