Investigating the effect of creatine supplementation on improving patient-reported functional outcomes after THA hip arthroplasty: A randomized, double-blind clinical trial

Investigating the effect of creatine supplementation on improving patient-reported functional outcomes after THA hip arthroplasty: A randomized, double-blind clinical trial

60 patients are selected and divided into two groups. The division of patients into exposure and control groups is done with the help of randomization software in a ratio of 1:1, and the allocation remains hidden from the researchers and the participating patients until the end of the study.

This study is a randomized, double-blind clinical trial conducted in the Orthopedic Department of Imam Khomeini Hospital among patients undergoing total hip arthroplasty. The aim is to evaluate the effect of oral creatine supplementation on postoperative functional recovery. Participants are randomly assigned to either the creatine or placebo group after providing written informed consent.

Inclusion criteria: aged 45 to 75 Both sexes Candidate for primary unilateral total hip replacement Exclusion criteria: Any previous history of hip surgery A history of cardiovascular, hepatic, endocrine, hematological, respiratory, or peripheral vascular disease A history of kidney disease or GFR less than 30 mL/min Active cancer A history of use of corticosteroids or anabolic steroids in the past 2 weeks

The intervention group consists of post-op patients who have undergone THA and, in addition to standard medications (cephalexin, acetaminophen, and NSAIDs), receive a creatine supplement powder at a dose of 5 grams once daily for 6 weeks after surgery. The control group consists of post-operative patients who have undergone total hip replacement and, in addition to standard medications, receive a placebo powder identical to the creatine at a dose of 5 grams daily for 6 weeks post-op.

Hip Abductor and Knee Extensor muscles volume

Randomization and Allocation Concealment A 1:1 randomization sequence was generated using a random number generator in a statistical software program to assign participants to either the creatine supplement or placebo group. To maintain balance in group sizes, random block sizes of 4 and 6 were used. The final allocation sequence was generated and kept by an independent statistician who was not involved in participant recruitment or assessment. Participant allocation was implemented using sequentially numbered, sealed, opaque envelopes to ensure allocation concealment, so that individuals involved in participant enrollment and assessment had no prior knowledge of the randomization sequence or group assignments. Blinding The study was conducted in a double-blind manner (participant and assessor). Neither the participants nor the outcome assessors were aware of the assigned interventions (creatine or placebo). The supplement and placebo were identical in appearance, packaging, and labeling. Only the research pharmacist, who had access to the randomization code, was authorized to break the code in emergency situations. Any code breaks were documented and will be reported in the final study report.

In this study, the patient and their clinical caregiver are specifically blinded. One group receives standard postoperative medications plus a creatine-like placebo for 6 weeks, and the other group receives 5 grams of creatine supplement daily for 6 weeks after surgery in addition to standard medications (cephalexin, acetaminophen, and NSAIDs).