Micronized creatine to help muscle strength and performance after knee replacement in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, randomized, placebo-controlled trial with two parallel arms testing creatine monohydrate given after total knee arthroplasty. Participants start a 12-week supplement course after surgery with a 1-week 20 g/day loading phase followed by 11 weeks of 5 g/day maintenance while undergoing usual outpatient rehabilitation. Main outcomes include muscle mass, muscle strength, sarcopenia status, frailty, functional capacity, and physical performance measured at baseline, 3 months, and 6 months. The trial is conducted at Consorci Sanitari del Maresme in Mataró, Barcelona and enrolls adults aged 65 and older having their first total knee replacement.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Persons 65 years of age or older who have been operated on for the first time for total knee arthroplasty,
* who are undergoing an outpatient rehabilitation program according to standard clinical practice,
* who sign the informed consent form.

Exclusion Criteria:

* Chronic renal disease at stage G3b or higher or glomerular filtration rate \<30 ml/min/1.73m2.
* Hepatic insufficiency, cirrhosis.
* Neuromuscular and neurodegenerative diseases (amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myasthenia gravis, Parkinson's disease, etc.).
* Severe or very severe chronic obstructive pulmonary disease (COPD) (GOLD III-IV).
* Moderate or severe chronic heart failure (NYHA 3-4).
* Central sensitivity syndrome (fibromyalgia and chronic fatigue syndrome).
* Moderate or severe cognitive impairment (GDS≥4).
* Moderate-severe dependence for basic activities of daily living (preintervention Barthel index \<60 points).
* Hemiparesis, amputation or malformation of any limb.
* Consumption of creatine monohydrate supplements in the last 6 months.

Where it's running

• Elisabet Palomera
  Mataró, Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Jéssica Martínez Rodríguez — Consorci Sanitari del Maresme
• Study coordinator: Jéssica Martínez Rodríguez
• Email: jmartinezro@csdm.cat
• Phone: 0034 937417700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.