Preventing Injured Knees From osteoArthritis: Severity Outcomes
A legfontosabb adatok
- Hol
- Atlanta, Boston, Chapel Hill, Cleveland, Columbus, Iowa City, Lexington, New York és Omaha (Egyesült Államok)Mind a 9 helyszín megnézése
- Fázis
- 2. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 45 év között vagy?
Forrás: NCT06096259: ki vehet részt
Helyszínek itt: Egyesült Államok
- Emory UniversityAtlanta, Egyesült ÁllamokContact: Gregory D Myer, PhD (principal investigator)Résztvevőt keres
- Brigham and Women's HospitalBoston, Egyesült ÁllamokContact: Rachel LovejoyRésztvevőt keres
- The University of North Carolina at Chapel HillChapel Hill, Egyesült ÁllamokContact: Joe M Hart, PhD (principal investigator)Résztvevőt keres
- Cleveland ClinicCleveland, Egyesült ÁllamokContact: Kurt Spindler, MD (principal investigator)Résztvevőt keres
- The Ohio State UniversityColumbus, Egyesült ÁllamokContact: Laura C Schmitt, PT, PhD (principal investigator)Résztvevőt keres
- University of Iowa Hospitals and ClinicsIowa City, Egyesült ÁllamokContact: Don D Anderson, PhD (principal investigator)Résztvevőt keres
- University of KentuckyLexington, Egyesült ÁllamokContact: Austin V Stone, MD, PhD (principal investigator)Résztvevőt keres
- Hospital for Special SurgeryNew York, Egyesült ÁllamokContact: Scott A Rodeo, MD (principal investigator)Résztvevőt keres
- University of Nebraska Medical CenterOmaha, Egyesült ÁllamokContact: Elizabeth A Wellsandt, PT, PhD (principal investigator)Résztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Brigham and Women's Hospital
- Azonosító
- NCT06096259
- A regiszteradat frissítve
- 2026. október 15.
- Eredeti leírás
This study is being done to find out if metformin is effective at reducing pain by delaying the onset of post-traumatic osteoarthritis (PTOA) after anterior cruciate ligament (ACL) reconstruction. This research study will compare metformin to placebo. The placebo tablet looks exactly like metformin, but contains no metformin. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.A teljes eredeti leírásKevesebb
Preventing Injured Knees From osteoArthritis: Severity Outcomes (PIKASO)
This study is being done to find out if metformin is effective at reducing pain by delaying the onset of post-traumatic osteoarthritis (PTOA) after anterior cruciate ligament (ACL) reconstruction. This research study will compare metformin to placebo. The placebo tablet looks exactly like metformin, but contains no metformin. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.
Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat type II diabetes. Notably, it also has anti-inflammatory effects, suggesting it could benefit people who have an ACL injury and are undergoing ACL reconstruction.
Bevonási feltételek: Age 25-45 or Age 18-24 with preoperative KOOS Pain <80 (0-100, 100 best) recorded at least 14 days after the day of ACL injury; Plan to undergo ACL reconstruction within 12 months of injury.
Kizáró feltételek: History of prior ACL tear on the index knee, with or without reconstruction; Applying for or receiving Workers' Compensation for their knee injury; Concomitant avulsion fracture of index knee that will be treated surgically; Concomitant posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament injury on index knee requiring surgical repair/reconstruction; Insufficient time for recruitment and drug titration: Surgery scheduled for <14 days from the time of screening; Diabetes mellitus or diabetic ketoacidosis; Acute or chronic renal insufficiency; History of ACL tear on the contralateral knee within the past 12 months; Diagnosis of cognitive impairment or otherwise unable to provide informed consent; Presence of a condition or abnormality that in the opinion of the surgeon investigator would compromise the safety of the patient or the quality of the data; Inflammatory arthritis; Pregnancy and/or lactation, or plans to become pregnant in the next 12 months; Known contraindication to metformin; Current use of metformin or topiramate; Joint space narrowing AND definite osteophyte(s) on weightbearing radiograph on index knee; Tibial plateau fracture on index knee; Contraindication to MRI; Unable to speak and understand English; Date of injury more than 6-months ago, relative to date of screening; Plan for allograft at time of consent.