Cementirana naspram bezcementne totalne artroplastike koljena istog modernog dizajna: prospektivno, randomizirano ispitivanje.
The Journal of bone and joint surgery. American volume
Sažetak istraživanja
Pozadina Vrlo porozne površine koje promovišu biološku fiksaciju obnovile su interes za totalnu artroplastiku koljena bez cementa (TKA), ali ostaje potencijal za neuspjelu biološku fiksaciju.
Svrha ove studije bila je uporediti kliničke ishode cementiranih i bescementnih verzija istog TKA dizajna u prosjeku 2 godine postoperativno.
Metode Ovo je bilo prospektivno, randomizirano kontrolirano ispitivanje koje je odobrio institucionalni odbor za pregled pacijenata od 18 do 75 godina koji su bili podvrgnuti primarnoj TKA. Pacijenti s upalnim artritisom, indeksom tjelesne mase (BMI) >40 kg/m, infekcijom, neuromuskularnim poremećajem ili ozbiljnim osteoporotičnim defektima kosti ili kostiju su isključeni. Pacijenti su randomizirani kako bi primili cementiranu ili bescementnu TKA istog dizajna s zadržavanjem ukrštenog zgloba. Implantat bez cementa ima visoko porozne površine za fiksiranje. Prikupljeni su rezultati Oxford Knee, Knee Society i Forgotten Joint Score. Od pacijenata je zatraženo da ocijene koleno sa TKA kao postotak normalnog. Analiza snage je pokazala da je bilo potrebno 130 pacijenata da bi se pokazala razlika od 5 poena u Oxford Knee Score-u pri 90% snage.
Rezultati Uključeno je 147 pacijenata, od kojih je 141 (96%) analiziran u prosjeku 2 godine postoperativno. Nije bilo razlike u dobi, polu, BMI, rezultatu Američkog društva anesteziologa (ASA) ili trajanju praćenja (p = 0,1 do 0,9). Takođe nije bilo razlike u promjeni nivoa hemoglobina od preoperativnog mjerenja do postoperativnog dana 1 između 2 kohorte (srednja i standardna devijacija, -2,6 ± 1,4 g/dL u poređenju sa -2,5 ± 0,9 g/dL, p = 0,5), ali je ukupno vrijeme operacije smanjeno u skupini bez cementa 82 . ± 16,7 minuta, p = 0,001). Nije bilo razlika ni u jednoj mjeri kliničkog ishoda nakon 4 do 6 sedmica, 1 godine ili u prosjeku 2 godine postoperativno (p = 0,1 do 0,9) između cementiranih i bezcementnih kohorti. Nije bilo radiografskih dokaza slijeganja ili labavljenja komponenti ni u jednoj kohorti.
Zaključci Ova studija je pokazala da je nedavno uvedena TKA bez cementa imala rezultate, i perioperativno i u prosjeku 2 godine postoperativno, koji su bili ekvivalentni onima njegovog cementiranog prethodnika, bez ikakvih aseptičkih kvarova bilo kojeg implantata. Stoga, ova studija opravdava kontinuirani nadzor ovog uređaja kako bi se razjasnilo njegovo preživljavanje i da li može pružiti bilo kakvu dugoročnu korist. Nivo dokaza Terapijski nivo I. Pogledajte Uputstva za autore za potpun opis nivoa dokaza.
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Cemented Versus Cementless Total Knee Arthroplasty of the Same Modern Design: A Prospective, Randomized Trial.
Background Highly porous surfaces promoting biologic fixation have renewed interest in cementless total knee arthroplasty (TKA), but the potential for failed biologic fixation remains. The purpose of this study was to compare the clinical outcomes of cemented and cementless versions of the same TKA design at an average of 2 years postoperatively.
Methods This was an institutional review board-approved, prospective, randomized controlled trial of patients from 18 to 75 years of age who were undergoing a primary TKA. Patients with inflammatory arthritis, a body mass index (BMI) of >40 kg/m, infection, a neuromuscular disorder, or grossly osteoporotic bone or bone defects were excluded. Patients were randomized to receive a cemented or cementless cruciate-retaining TKA of the same design. The cementless implant has highly porous fixation surfaces. Oxford Knee, Knee Society, and Forgotten Joint Scores were collected. Patients were asked to rate the knee with the TKA as a percentage of normal. Power analysis indicated that 130 patients were necessary to demonstrate a 5-point difference in the Oxford Knee Score at 90% power.
Results One hundred and forty-seven patients were enrolled, and 141 (96%) of them were analyzed at an average of 2 years postoperatively. There was no difference in age, sex, BMI, American Society of Anesthesiologists (ASA) score, or duration of follow-up (p = 0.1 to 0.9). There was also no difference in the change in the hemoglobin level from the preoperative measurement to postoperative day 1 between the 2 cohorts (mean and standard deviation, -2.6 ± 1.4 g/dL compared with -2.5 ± 0.9 g/dL, p = 0.5), but the total operative time was decreased in the cementless cohort (82.1 ± 16.6 compared with 93.7 ± 16.7 minutes, p = 0.001). There were no differences in any clinical outcome measure at 4 to 6 weeks, 1 year, or an average of 2 years postoperatively (p = 0.1 to 0.9) between the cemented and cementless cohorts. There was no radiographic evidence of component subsidence or loosening in either cohort.
Conclusions This study demonstrated that a recently introduced cementless TKA had results, both perioperatively and at an average of 2 years postoperatively, that were equivalent to those of its cemented predecessor, without any aseptic failures of either implant. Thus, this study justifies continued surveillance of this device to elucidate both its survivorship and if it can provide any long-term benefits. Level of evidence Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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- DOI
- 10.2106/jbjs.18.01162
- PMID
- 31274720
- PMCID
- PMC6641115
- Provjereno
- 2026-07-26
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