A 20-patient pilot study found that augmenting hip fracture repair with a calcium sulfate/hydroxyapatite biomaterial combined with systemic zoledronic acid was safe and showed preliminary signals of enhanced bone formation around the implant, though the sample size was very small and follow-up data limited.
Trochanteric fractures (breaks in the upper thighbone) are common in older adults with osteoporosis and frequently require surgical fixation. The challenge isn't just closing the fracture; it's ensuring the bone around the implant heals robustly, especially in patients with weakened bone quality. This pilot study tested whether adding a biomaterial directly to the fracture site combined with a bone-strengthening drug could improve outcomes.
The intervention group received a proximal femoral nail (the standard surgical implant) augmented with calcium sulfate/hydroxyapatite paste injected around the helical blade, followed by a single intravenous dose of zoledronic acid seven days after surgery. The control group received the standard nail alone, plus the same zoledronic acid infusion. Twenty patients were enrolled, but only 10 completed the study with evaluable outcome data: five in each group. The median age was 81 years, and most participants were female (70%).
The augmented group demonstrated a more pronounced increase in peri-implant bone mineral density at six months compared to controls. Tip-apex distance (a measure of potential implant migration) changed more in the control group, suggesting the biomaterial may have provided better local bone support. Functional outcomes measured by the Harris Hip Score showed slightly greater improvement in the augmented group, though differences were modest. Critically, there were no intraoperative complications or adverse effects attributed to the calcium sulfate/hydroxyapatite biomaterial, and only one patient (in the control group) died within the first week before receiving zoledronic acid.
The study's primary limitation is severe: only 50% of enrolled patients had complete outcome data available for analysis. One patient died preoperatively, and data extraction failed for nine others, suggesting either loss to follow-up, missing imaging, or functional assessment documentation. This drops the effective sample to a pilot-scale N of 10, which substantially limits confidence in the magnitude of differences observed. The findings constitute proof-of-concept that the approach is feasible and tolerable, not evidence of clinical efficacy.
If you are facing trochanteric fracture surgery, particularly with diagnosed osteoporosis, this research indicates that biomaterial augmentation is not contraindicated and may offer local bone-healing advantages. However, this is preliminary data from a very small sample. Current standard-of-care zoledronic acid infusion (already given to both groups) remains the established pharmacological approach for reducing fracture-related complications in this population. Any decision to use augmentation should be made in consultation with your orthopedic surgeon based on your specific fracture anatomy and bone quality, not on the basis of this pilot study alone.
The study provides no guidance on vitamin-d, calcium, or other systemic bone health interventions, which remain relevant independent considerations for osteoporosis management alongside surgical decisions.
| Characteristic | Details |
|---|---|
| Study type | Randomized controlled pilot trial |
| Sample size | 20 enrolled; 10 with complete outcome data (5 per group) |
| Participants | Patients aged 65-90 with osteoporotic trochanteric fractures |
| Intervention | Proximal femoral nail + calcium sulfate/hydroxyapatite biomaterial + IV zoledronic acid (day 7 post-op) |
| Control | Proximal femoral nail + IV zoledronic acid (day 7 post-op) |
| Primary outcome | Change in peri-implant bone mineral density at 1 week and 6 months |
| Secondary outcomes | Tip-apex distance (implant migration), Harris Hip Score (function), fracture union |
| Key findings | Augmented group showed greater BMD increase; less implant migration; slightly better functional scores; no adverse events |
| Study duration | December 2023 to January 2025 (enrollment period) |
| Limitations | High rate of incomplete data (50% dropout/missing data); very small final sample; single-center design; no long-term follow-up beyond 6 months |
| Journal | Joint Diseases and Related Surgery |
Study: Gül S, et al. Safety and feasibility of calcium sulfate/hydroxyapatite with zoledronic acid for the augmentation of helical blades in trochanteric fractures: A randomized pilot study. *Joint Diseases and Related Surgery*. PubMed: 42542929
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| PubMed ID |
| 42542929 |