Efficacy of Injectable Calcium Composite Bone Substitute Augmentation for Osteoporotic Intertrochanteric Fractures: A Prospective, Non-Randomized Controlled Study.

Background/

Objectives

Femoral intertrochanteric fractures (ITFs) in older adults are associated with a substantial risk of mechanical failure after fixation, which can lead to persistent pain, delayed mobilization, and increased mortality. Injectable calcium composite bone substitute (ICCBS) augmentation has been proposed as a strategy to enhance construct stability and promote bone healing, but clinical evidence remains limited. The purpose of this study was to evaluate the efficacy of ICCBS in the management of osteoporotic ITFs.

Methods

We conducted a multicenter, prospective, non-randomized controlled study of patients undergoing surgical fixation for osteoporotic ITFs using proximal femoral nails. Patients who consented to augmentation received ICCBS, while the control group underwent standard fixation alone. Demographic and injury-related variables were documented, and outcome data were prospectively collected. The primary outcome was time to radiographic bone union, while secondary outcomes included functional recovery (pain and ambulatory status) and complications, including fixation failure.

Results

The mean time to radiographic bone union did not differ significantly between groups (p = 0.28). However, patients receiving ICCBS augmentation reported significantly lower postoperative pain scores up to 6 weeks and demonstrated reduced lag screw sliding and varus collapse at the time of bone union. There were no significant differences in complication rates, fixation failure, or ambulatory status at last follow-up between the two groups.

Conclusions

ICCBS augmentation may improve early postoperative pain, construct stability, and functional recovery in patients with osteoporotic ITFs, although its effect on fracture healing and long-term outcomes remains uncertain. Further high-quality randomized trials are warranted to confirm these findings.