title: Prospective Randomized Study of Objective and Subjective Clinical Results Between Double-Bundle and Single-Bundle Anterior Cruciate Ligament Reconstruction.
abstract: BACKGROUND
  There is controversy as to whether double-bundle anterior cruciate ligament (ACL) reconstruction with hamstring tendon graft (DB-HT) or single-bundle ACL reconstruction with patellar tendon graft (SB-PT) obtains the best clinical outcomes.
  
  
  OBJECTIVE
  To compare the short-term clinical outcomes of DB-HT with those of rectangular-tunnel SB-PT (RTSB-PT) at 2-year follow-up and to identify the factors that affect subjective knee functional score.
  
  
  METHODS
  Randomized controlled trial. Level of evidence, 1.
  
  
  METHODS
  Sixty-three male patients (mean age, 26.1 years) and 87 female patients (mean age, 25.8 years) were included in this study and were randomly distributed to either the DB-HT (n = 76) or RTSB-PT (n = 74) group. Clinical outcomes (knee flexion range of motion [ROM], heel-height difference, side-to-side difference in anterior laxity, rotational laxity, and Tegner activity score) were compared between the DB-HT and RTSB-PT groups, and examination of factors affecting subjective outcomes (Knee Injury and Osteoarthritis and Outcome Score [KOOS] results) was performed by multiple linear regression analysis.
  
  
  RESULTS
  Fourteen patients (9 DB-HT, 5 RTSB-PT) had secondary ACL injury within 2 years after primary ACL reconstruction and were excluded from analysis. In the examination of 136 patients at the 24-month follow-up, there was no significant difference between the 2 groups in clinical or subjective outcomes. The normalized knee extensor strength of the RTSB-PT group showed negative surgical technique effect in the early postoperative phase (P = .005), but there was no significant difference between the 2 groups at the 24-month follow-up (P = .114). There was no significant difference in change of normalized knee flexor strength between the 2 groups (P = .493). Age, sex, body mass index (BMI), and presence of meniscus injury were the factors that affected KOOS subscale scores.
  
  
  CONCLUSIONS
  In this prospective randomized controlled study, there was no significant difference in the incidence of secondary ACL injury and no difference in objective or subjective outcomes between the DB-HT and RTSB-PT reconstruction at 24-month follow-up. Age, sex, presence of meniscus injury, and BMI affected subjective KOOS subscale scores, while surgical technique did not.
authors.affiliation: Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan ss422412@rmail.plala.or.jp.
authors.forename: Shizuka
authors.initials: S
authors.lastname: Sasaki
authors.affiliation: Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
authors.forename: Eiichi
authors.initials: E
authors.lastname: Tsuda
authors.affiliation: Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Hiraga
authors.affiliation: Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
authors.forename: Shugo
authors.initials: S
authors.lastname: Maeda
authors.affiliation: Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Sasaki
authors.affiliation: Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Ishibashi
mesh_terms: D000328:Adult; D000367:Age Factors; D059549:Anterior Cruciate Ligament Reconstruction / Q000379:methods*; D015992:Body Mass Index; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007719:Knee Joint / Q000502:physiology; D008297:Male; D053580:Muscle Strength / Q000502:physiology; D063868:Patient Outcome Assessment; D011446:Prospective Studies; D012737:Sex Factors
keywords: anterior cruciate ligament; double-bundle; randomized control trial; single-bundle