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Receiving protein can affect the bone formation and maintenance by providing a structural matrix of the bone, optimizing the level of IGF-1, increasing intestinal calcium absorption, transferring phosphorous, and improving muscle strength.Therefore, protein may be effective on vertebral fusion by such mechanisms. In this trial patients undergoing elective posterior spine fusion surgery are divided into two groups of intervention or control.
A randomized, double blind, controlled trial will be conducted in patients undergoing elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 80 eligible posterior spine fusion surgery patients, aged ≥ 18 years. Intervention patients will be received 36 grams of protein supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and control patients will be received Carbo Mass along with diet containing 1.2 g/kg/day of protein 30 days after surgery. Patients will be evaluated for occurrence of vertebral fusion and enhanced recovery after 3 months surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| protein supplement | Experimental | Intervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery. |
|
| Carbo Mass | Placebo Comparator | Control patients will be received protein diet (1.2 g/kg/day) and Carbo Mass for 1 month after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| protein supplement | Drug | Three sachet of protein supplement to be mixed in with water used daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of vertebral fusion in CT scan | Rate of formation of a solid bony Union in CT scan | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of wound healing | Rate of wound healing, the sutures of the surgery, inspected by granulation tissue formation. | Discharge, 15 days and 1 month after surgery |
| Rate of of wound infection | Rate of of wound infection, revealed by physical examination |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| zahra vahdat shariatpanahi, MD,PhD | Faculty of Nutrition and Food Technology, SBMU | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zahra vahdat shariatpanahi | Tehran | +98 | Iran |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
| Carbo Mass | Other | Three sachet of Carbo Mass supplement to be mixed in with water used daily. |
|
| 15 days, 1 and 3 month after surgery |
| score of pre and postoperative pain | pain measured by the visual analogue scale or visual analog scale (VAS) questionnaire | baseline, discharge, 15 days 1 and 3 month after surgery |
| Concentration of serum IGF-1 | Concentration of Insulin-like growth factor-1 | baseline, 1 month after surgery |
| Concentration of serum albumin | Concentration of serum albumin | baseline, 1 month after surgery |
| Concentration of serum total protein | Concentration of serum total protein | baseline, 1 month after surgery |
| Concentration of serum hsCRP | Concentration of serum high-sensitivity C-reactive protein | baseline, 48 hour,15 days and 1 month after the surgery |