Micronized creatine to help muscle strength and performance after knee replacement in older adults
Efficacy of Supplementation With Micronized Creatine Monohydrate in the Recovery of Muscle Mass, Muscle Strength and Functional Capacity in Older Adults Operated on for Total Knee Arthroplasty: Randomized Clinical Trial
This trial will test whether taking daily creatine for 12 weeks after knee replacement helps people 65 and older keep muscle, regain strength, and recover function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 262 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Consorci Sanitari del Maresme Academic / other |
| Locations | 1 site (Mataró, Barcelona) |
| Trial ID | NCT06925880 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 65 or older having their first total knee arthroplasty who will attend standard outpatient rehabilitation and can provide informed consent.
Not a fit: Patients with advanced kidney disease (eGFR <30), significant liver disease, major neuromuscular or neurodegenerative conditions, severe heart or lung failure, major cognitive impairment, or high preoperative dependence are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, creatine supplementation could help older patients preserve muscle, speed strength recovery, and improve functional outcomes after knee replacement.
How similar studies have performed: Previous research has shown creatine can improve muscle mass and strength in older adults, but its specific use immediately after knee replacement is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mataró, Barcelona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.