Prospective Randomized Study of Objective and Subjective Clinical Results Between Double-Bundle and Single-Bundle...

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.

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.

Randomized controlled trial. Level of evidence, 1.

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.

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.

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.