Spinal Stenosis Clinical Trial
Official title:
Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?
Verified date | April 2019 |
Source | University Hospital, Linkoeping |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | January 1, 2019 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - lumbar spinal stenosis operated on with decompression and bone grafting. All ages are accepted, but women must be postmenopausal. Exclusion Criteria: - •dementia or psychiatric disorder - known malignancy < 5 years prior to fracture - calcium above reference value - signs of liver disease - creatinine over ref. value - inflammatory joint disease - alcohol or drug abuse - oral corticosteroid medication - long-term NSAID-treatment (=> 3 months prior to fracture) |
Country | Name | City | State |
---|---|---|---|
Sweden | Ortopedkliniken | Kalmar | |
Sweden | Ryggkliniken, US Linköping | Linköping |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping | Medical Research Council of Southeast Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months + more than 2 years postoperatively. | |
Secondary | Pain | Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain. | At 3 and 6 months. | |
Secondary | Function | Function is evaluated using Oswestry Disability Index. Zero is equated with no disability and 100 is the maximum disability possible. | At 3 and 6 months. |
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