A prospective comparison of 3 hamstring ACL fixation devices--Rigidfix, BioScrew, and Intrafix--randomized into 4 groups with 2 years of follow-up.
Am J Sports Med
; 37(4): 699-706, 2009 Apr.
Article
in En
| MEDLINE
| ID: mdl-19188561
ABSTRACT
BACKGROUND:
New devices for graft fixation in anterior cruciate ligament reconstruction are released to clinical use without clinical follow-up data.HYPOTHESIS:
There is similar clinical outcome after either cross-pin or absorbable interference screw fixation in anterior cruciate ligament reconstruction with hamstring tendons. STUDYDESIGN:
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).CONCLUSION:
There were no statistically or clinically relevant differences in the results 2 years postoperatively, and all 4 techniques improved patient performance.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Arthroplasty
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Tendons
/
Anterior Cruciate Ligament
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Joint Instability
/
Knee Injuries
Type of study:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Limits:
Adolescent
/
Adult
/
Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
Am J Sports Med
Year:
2009
Document type:
Article
Affiliation country: