Parathyroid (PTH) hormone has been shown to enhance fracture healing in animal studies. There are so far only three published papers concerning humans. Postero-lateral fusions have shown a healing rate of less than 50% after bone. The purpose of this study is to determine if PTH 1-34 (teriparatide) improves the healing rate and the clinical course after spinal stenosis surgery.
100 patients undergoing surgery due to spinal stenosis and intraoperatively treated with autologous bone graft, will be randomised to either 4 weeks of daily injections with teriparatide or control. Primary outcome: The rate of healing at 6 months on CT Scans. Secondary outcomes; Pain (VAS), function (Oswestry Disability Index), quality of life (EQ-5D) at 3 and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks
Ortopedkliniken
Kalmar, Sweden
Ryggkliniken, US Linköping
Linköping, Sweden
The rate of bone healing after spinal stenosis surgery
A radiologist, blinded to the treatment, will review all CT scans and judge whether there is a bony healing between the vertebrae.
Time frame: 6 months + more than 2 years postoperatively.
Pain
Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.
Time frame: At 3 and 6 months.
Function
Function is evaluated using Oswestry Disability Index. Zero is equated with no disability and 100 is the maximum disability possible.
Time frame: At 3 and 6 months.
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