Table 5.
Long-Term Follow-Up RCTs
| RCT | Level of Evidence | Subgroup | Interventions | Outcome measures | Results |
|---|---|---|---|---|---|
| Bottoni et al., 201521 | I | Allograft | Hamstring autograft vs tibialis posterior allograft at minimum 10 years (n = 96/99) | Graft failure, subjective knee stability and functional status SANE, Tegner, and IKDC scores. | 4 (8.3%) autograft vs 13 (26.5%) allograft failures required revision. In remaining patients whose graft was intact, there was no difference in functional scores. |
| Sundaraj et al., 202066 | I | Biofixation | Bioabsorbable vs titanium screws (hamstring autograft) at 13 years (n = 40) | IKDC, KT-1000, MRI-tunnel volumes, ossification around screw, graft integration, and cyst formation. | No significant differences between the groups. |
| Stensbirk et al., 201470 |
I | Different autografts | Iliotibial band vs BPTB at 15 years (n = 49/60) | Failure rate, KOOS, Tegner, anterior knee pain, Lysholm score, Rolimeter laxity, extension deficit. | No significant differences between the groups. |
| Castoldi et al., 202060 | II | EAT | BPTB +/– lateral extra-articular tenodesis at 19.4 years (n = 79/121) | Clinical outcomes, IKDC, radiographs | No significant differences between the groups although more lateral OA in EAT group (59% vs 22%; P = .02; n = 45/121). |
| Meunier et al., 200759 |
II | Others | Operative vs non-op at 15 years’ FU (n = 100) | KOOS, Lysholm, OA | No significant differences between the groups, ACLR neither reduced risk of OA nor increased subjective outcome scores. However, there were significantly more meniscus injuries in patients initially treated nonoperatively; 1/3 nonoperative patients later had ACLR for instability. |
| Holm et al., 201261 | II | Others | Open vs arthroscopic at 12 years (n = 53/67) | Prevalence of OA on radiographs, Cincinnati score, clinical assessments | No significant differences between the groups (OA: 79% vs 80%) |
| Sajovic et al., 201862 | II | Patella vs hamstrings | Patellar vs hamstring autografts at 17 years (n = 48/64) | IKDC, KT-1000 arthrometer, and radiography, SF -36, graft failure | No significant differences between the groups although more OA with patella (100% vs 71%; (P = .004). |
| Björnsson et al., 201667 | II | Patella vs hamstrings | Patellar vs hamstrings autografts at 16 years (n = 147/193) | Laxity measurements, functional outcomes, PROMS, bilateral standing radiographs | No significant differences between the groups, significantly more signs of OA in the reconstructed knee vs contralateral knee. |
| Webster et al., 201669 | I | Patella vs hamstrings | Patellar vs hamstrings at 15.3 years (n = 47/65) | Clinical assessment, anterior pain, laxity, ROM, radiographic outcomes | No significant difference between the groups. |
| Barenius et al., 201463 | I | Patella vs hamstrings | Patella vs hamstrings at 14 years (n = 135/164) | Radiological examination, Tegner, KOOS | No significant difference between the groups. (OA 49% vs 65%; P = .073). |
| Konrads et al., 201668 | II | Patella vs hamstrings | Patella vs hamstrings at 10 years (n = 47/62) | KT-1000, VAS, IKDC, Lysholm score, Tegner scale, and standard radiographs | No significant difference between the groups. |
| Sporsheim et al., 201964 | I | Repair | Open repair methods: acute primary repair, acute repair with a ligament augmentation device or BPTB ACLR at 30 years (n = 113/150) | Tegner and Lysholm questionnaires, radiographic examination, revisions and knee arthroplasties. | Prevalence of OA 42%, BPTB had significantly less rate of revision. No significant differences between the groups (remaining patients) |
| Järvelä et al., 201765 |
II | Single- vs double- bundle | Single- (bio-screw) vs single- (metal-screw) vs double-bundle (bioscrew) at 10 years’ FU (n = 81/90) | KT-1000, IKDC, Lysholm scores, radiographic examination | Revision: 1 DB vs 7 SB-Bio vs 3 SB-metal (P = .043). No significant differences between the groups in clinical outcomes or OA (38% vs 28% contralateral knee). |
| Annear et al., 201971 | II | Technique | Remnant ACL preservation vs debridement graft hamstring autograft at 10 years (n = 44/49) | Graft failure rates, subjective outcomes | No significant differences between the groups. |
| Drogset et al., 200640 | II | Technique | Acute primary repair, acute repair augmented with a synthetic ligament-augmentation device or acute repair with autologous BPTB graft at 16 years (n = 129/147) | Tegner activity score and Lysholm functional score. Stability (clinical examination and KT-1000 arthrometer). | Revision rate: 24%, 10%, and 2% respectively. The rate of revision was 10 times greater in the group that had primary repair than in the group that had repair with BPTB (P = .003) and the latter had significantly better stability (Lachman). OA changes noted in 11% in the reconstructed knee vs 3.5% in the contralateral knee (P = .001); no differences between groups. |
ACL, anterior cruciate ligament; ACLR, anterior cruciate ligament reconstruction; BPTB, bone–patella tendon–bone; DB, double bundle; FU, follow-up; IKDC, International Knee Documentation Committee; KOOS, Knee Injury and Osteoarthritis Outcome Score; MRI, magnetic resonance imaging; OA, osteoarthritis; PROM, patient-reported outcome measures; RCT, randomized controlled trial; ROM, range of motion; SANE, Single Assessment Numerical Evaluation; SB, single bundle; SF-36, Short Form-36; VAS, visual analog scale.