Biodegradable implants versus standard metal fixation for displaced radial head fractures. A prospective, randomized, multicenter study.
This multicenter, prospective, randomized study compares the use of biodegradable polylactide pins with standard metal mini-fragment implants for the treatment of displaced radial head fractures. It compares complication rates and clinical outcomes of both treatment methods. At 2 years, 135 (82%) of 164 patients were available for evaluation. Equivalence of treatment method was defined as a difference of 10% or less in the number of complication-free patients. Functional status was assessed by using the Broberg and Morrey Elbow Score and compared by an unpaired t test. Good or excellent clinical results were achieved by 92% (56/61) of the control patients and 96% (71/74) of the polylactide patients. The incidence of complication-free patients was 3.7% less in the polylactide group than in the control group. The 1-sided 95% confidence interval for the treatment difference between the 2 groups was more than -6.1%. Biodegradable polylactide pins have at least comparable outcomes as standard metal implants for the internal fixation of reconstructable displaced radial head fractures.
Helling
Hanns-Joachim
HJ
Department of Trauma- Hand- and Reconstructive Surgery, University Hospital Cologne, Köln, Germany.
Prokop
Axel
A
Schmid
Hans Ulrich
HU
Nagel
Michael
M
Lilienthal
Jürgen
J
Rehm
Klaus Emil
KE
D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D000368:Aged; D001858:Bone Nails; D004551:Elbow Joint / Q000601:surgery*; D005260:Female; D005592:Fracture Fixation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011091:Polyesters; D011446:Prospective Studies; D011885:Radius Fractures / Q000601:surgery*; D000092464:Elbow Injuries
D011091:Polyesters; C033616:poly(lactide)