Study design:

A prospective and non-randomized concurrent controlled trial.

Objective:

To address the early effects of concurrent treatment with vitamin K2 and vitamin D3 on fusion rates in patients who have undergone spinal surgery.

Summary of background data:

Intervertebral pseudarthrosis has been reported after transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody fusion (PLIF), especially in patients with osteopenia or osteoporosis. No study has assessed the early effects of concurrent treatment with vitamin K2 and vitamin D3 on fusion rates.

Methods:

Patients with osteopenia or osteoporosis who underwent TLIF or PLIF in our department were included. Patients in the VK2+VD3 group received vitamin K2, vitamin D3 and calcium treatment, while subjects in the control group only received Calcium and vitamin D3. Spine fusion was evaluated by computed tomography. The Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOA-BPEQ) and visual analog scale (VAS) were used to assess the clinical and neurological symptoms. Bone mineral density (BMD) and bone metabolism markers were measured for osteoporotic evaluation.

Results:

Seventy-eight patients were included, and nine patients subsequently discontinued because of 2019-nCoV. At six months postoperatively, complete fusion rates were significantly higher in the VK2+VD3 group than that in the control group (91.18% vs 71.43%, p = 0.036). At six months postoperatively, BMD was increased in the VK2+VD3 group and was higher than that in the control group, although there was no significant difference. At three months postoperatively, a significant increase in P1NP (91.81%) and a slight decrease in β-CROSS (8.06%) were observed in the VK2+VD3 group. In both groups, the JOA-BPEQ and VAS scores were significantly improved after spine surgery.

Conclusion:

Administration of vitamin K2 and vitamin D3 can increase lumbar interbody fusion rates, improve clinical symptoms, promote bone information and avoid further decline in BMD within six months after TLIF or PLIF.Level of Evidence: 3.