A prospective comparison of 3 hamstring ACL fixation devices--Rigidfix, BioScrew, and Intrafix--randomized into 4 groups with 2 years of follow-up.
BACKGROUND
New devices for graft fixation in anterior cruciate ligament reconstruction are released to clinical use without clinical follow-up data.


OBJECTIVE
There is similar clinical outcome after either cross-pin or absorbable interference screw fixation in anterior cruciate ligament reconstruction with hamstring tendons.


METHODS
Randomized controlled clinical trial; Level of evidence, 1.


METHODS
A total of 120 patients were randomized into 4 different groups (30 each) for anterior cruciate ligament reconstruction with hamstring tendons: femoral Rigidfix cross-pin and Intrafix tibial expansion sheath with a tapered expansion screw; Rigidfix femoral and BioScrew interference screw tibial fixation, BioScrew femoral and Intrafix tibial fixation; or BioScrew fixation into both tunnels. The evaluation methods were clinical examination, knee scores, and instrumented laxity measurements.


RESULTS
Ten patients were completely lost to follow-up and 3 revisions were done before the 2-year follow-up, leaving 107 of 120 (89%) patients for analysis. No statistically significant differences between the groups were seen 2 years postoperatively, and all but 2 patients in the Rigidfix/Intrafix and Rigidfix/BioScrew groups, respectively, were classified into International Knee Documentation Committee A or B categories. A revision reconstruction was performed before the 2-year follow-up in 2 cases after a high-energy injury caused a rerupture (1 in Rigidfix/Intrafix and 1 in BioScrew/BioScrew groups). In addition, there were 4 nontraumatic failures revised before the 2-year follow-up (2 in Rigidfix/Intrafix and 1 each in Rigidfix/BioScrew and BioScrew/BioScrew).


CONCLUSIONS
There were no statistically or clinically relevant differences in the results 2 years postoperatively, and all 4 techniques improved patient performance.
Harilainen
Arsi
A
ORTON Orthopaedic Hospital, Invalid Foundation, Helsinki, Finland. arsi.harilainen@orton.fi
Sandelin
Jerker
J
D000293:Adolescent; D000328:Adult; D016118:Anterior Cruciate Ligament / Q000601:surgery*; D000070598:Anterior Cruciate Ligament Injuries; D053587:Arthrometry, Articular; D001178:Arthroplasty / Q000295:instrumentation*; D001858:Bone Nails; D001863:Bone Screws; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007593:Joint Instability / Q000601:surgery*; D007718:Knee Injuries / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013710:Tendons / Q000637:transplantation*; D019415:Torque; D055815:Young Adult