Trial of Protein Supplement on Vertebral Fusion in Posterior Spine Fusion Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04091841|
Recruitment Status : Active, not recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spine Surgery||Drug: protein supplement Other: Maltodextrine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Protein Supplement on Vertebral Fusion and Enhanced Recovery After Posterior Spine Fusion Surgery|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: protein supplement
Intervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery.
Drug: protein supplement
Three sachet of protein supplement to be mixed in with water used daily.
Other Name: Pure-protein
Placebo Comparator: maltodextrin
Control patients will be received protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery.
Three sachet of Maltodextrine supplement to be mixed in with water used daily.
- Rate of vertebral fusion in CT scan [ Time Frame: 3 months after surgery ]Rate of formation of a solid bony Union in CT scan
- Rate of wound healing [ Time Frame: 48 hour, 10 days and 1 month after surgery ]Rate of wound healing, the sutures of the surgery, inspected by granulation tissue formation.
- Rate of of wound infection [ Time Frame: 48 hour and 10 days after surgery ]Rate of of wound infection, revealed by physical examination
- score of pre and postoperative pain [ Time Frame: baseline, 48 hour, 10 days 1 and 3 month after surgery ]pain measured by the visual analogue scale or visual analog scale (VAS) questionnaire
- Concentration of serum IGF-1 [ Time Frame: baseline, 1 month after surgery ]Concentration of Insulin-like growth factor-1
- Concentration of serum albumin [ Time Frame: baseline, 1 month after surgery ]Concentration of serum albumin
- Concentration of serum total protein [ Time Frame: baseline, 1 month after surgery ]Concentration of serum total protein
- Concentration of serum hsCRP [ Time Frame: baseline, 10 days after the surgery ]Concentration of serum high-sensitivity C-reactive protein
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091841
|Iran, Islamic Republic of|
|Zahra vahdat shariatpanahi|
|Tehran, Iran, Islamic Republic of, +98|
|Study Chair:||zahra vahdat shariatpanahi, MD,PhD||Faculty of Nutrition and Food Technology, SBMU|