A pilot clinical evaluation comparing the Mitek bone-tendon-bone cross pin and bioabsorbable screw in anterior cruciate ligament reconstruction fixation, a randomized double blind controlled trial.
OBJECTIVE
To compare the clinical efficacy of ACL reconstruction using the Mitek bone-tendon-bone cross pin (RIGIDfix) to the Linvatec Bioscrew (control device).


METHODS
Forty subjects were randomized into one of two groups: the RIGIDfix or control group. Eligible subjects were male and female, 18 years of age and older, with an ACL injury of at least 3 weeks duration and no evidence of ACL insufficiency on the contralateral side. Subjects were followed for 24-month post-operatively. Evaluations included the International Knee Documentation Committee (IKDC) Knee Ligament Standard Evaluation, Mohtadi's ACL Deficiency Quality of Life (ACL-QOL) questionnaire and the attainment of six rehabilitation milestones. Subjects and assessors were blinded to the surgical device used.


RESULTS
Four subjects in the RIGIDfix group and four controls were lost to follow-up. The change in final IKDC scores did not differ significantly between groups with the majority demonstrating an improvement of one to two grades. The change in ACL-QOL scores did not differ significantly between the RIGIDfix subjects (40.0+4.4) and controls (46.0+3.6). Furthermore, the number of weeks that the RIGIDfix subjects versus controls attained full active extension, functional range of motion, normal gait, stair climbing, running gait and sprinting did not differ significantly.


CONCLUSIONS
The RIGIDfix results in a similar post-operative course to the control device and is efficacious for the reconstruction of the ACL. No adverse events were associated with the use of the RIGIDfix. The results of this study should be considered preliminary due to the small sample size.
Marks
Paul
P
Department of Orthopaedic Surgery, Holland Orthopaedic & Arthritic Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. paul.marks@sunnybrook.ca
O'Donnell
Siobhan
S
Yee
Gilbert
G
D020341:Absorbable Implants; D000328:Adult; D016118:Anterior Cruciate Ligament / Q000601:surgery*; D000070598:Anterior Cruciate Ligament Injuries; D001858:Bone Nails; D001863:Bone Screws; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011474:Prosthesis Design; D016059:Range of Motion, Articular; D016896:Treatment Outcome