Table 2.
Patient reported outcomes and mechanical knee stability measures at five years and change between two and five years for full analysis set (n=120)
| Outcome | Early ACL reconstruction (n=61) |
Delayed optional ACL reconstruction (n=59) |
Mean difference (95% CI) | P value |
|---|---|---|---|---|
| Mean (95% CI) follow-up after randomisation (months) | 60 (59 to 61) | 59 (57 to 60) | 1.2 (−0.6 to 3.0) | 0.06 |
| Patient reported outcomes at 5 years | ||||
| Mean (95% CI) KOOS*: | ||||
| KOOS4† | 80 (76 to 84) | 82 (77 to 86) | −1.5 (−7.4 to 4.4) | 0.45 |
| Pain | 91 (88 to 94) | 91 (88 to 94) | −0.3 (−4.6 to 4.0) | 0.73 |
| Symptoms | 83 (78 to 87) | 87 (83 to 91) | −4.4 (−10.2 to 1.4) | 0.12 |
| Activities of daily living | 95 (93 to 98) | 97 (95 to 99) | −1.5 (−4.3 to 1.4) | 0.38 |
| Sport and recreation | 76 (70 to 82) | 79 (73 to 86) | −3.3 (−11.7 to 5.2) | 0.23 |
| Knee related QOL | 71 (66 to 76) | 69 (63 to 75) | 1.8 (−6.2 to 9.8) | 0.89 |
| Mean (95% CI) SF-36‡: | ||||
| Physical component | 85 (81 to 89) | 84 (80 to 89) | 0.9 (−4.9 to 6.7) | 0.78 |
| Mental component | 87 (84 to 91) | 85 (84 to 91) | 2.8 (−2.7 to 8.3) | 0.34 |
| Median (interquartile range) Tegner activity scale§ | 4 (2.5-7) | 4 (2-7) | 0.1 (−0.8-1.1) | 0.74 |
| No (%) active at pre-injury Tegner activity scale level¶ | 14 (23) | 12 (20) | 2.6 (−12.4-17.6)‡ | 0.73 |
| Mechanical knee stability at 5 years | ||||
| No (%) normal Lachman test** | 45/58 (76) | 19/58 (33) | 43.5 (27.0 to 60.1)†† | <0.001 |
| No (%) normal pivot shift test‡‡ | 45/58 (76) | 23/58 (40) | 36.6 (19.7 to 53.5)†† | <0.001 |
| Change in patient reported outcomes (5 minus 2 years) | ||||
| Mean (95% CI) KOOS: | ||||
| KOOS4 | 4 (1 to 8) | 5 (1 to 10) | −1.3 (−6.7 to 4.2) | 0.38 |
| Pain | 4 (1 to 7) | 4 (0 to 7) | 0.3 (−3.9 to 4.4) | 0.86 |
| Symptoms | 4 (0 to 8) | 4 (0 to 8) | 0.0 (−5.5 to 5.6) | 0.87 |
| Activities of daily living | 2 (0 to 4) | 2 (0 to 4) | −0.2 (−3.0 to 2.6) | 0.76 |
| Sport and recreation | 5 (1 to 10) | 8 (2 to 14) | −3.5 (−11.6 to 4.7) | 0.27 |
| Knee related QOL | 4 (0 to 8) | 6 (0 to 12) | −2.0 (−9.2 to 5.1) | 0.35 |
| Mean (95% CI) SF-36: | ||||
| Physical component | 4 (−1 to 8) (n=60) | 6 (3 to 10) | −1.7 (−6.9 to 3.5) | 0.12 |
| Mental component | −1 (−5 to 3) | 1 (−3 to 4) | −1.7 (−6.9 to 3.5) | 0.52 |
ACL=anterior cruciate ligament; KOOS=knee injury and osteoarthritis outcome score; QOL=quality of life.
*KOOS ranges from 0 to 100, with higher scores indicating better results.12, 13
†Includes four KOOS subscales: pain, symptoms, function in sports and recreation, and knee related quality of life; scores range from 0 to 100, with higher scores indicating better results.7
‡Scores range from 0 to 100, with higher scores indicating better results.14
§Assesses activity level with specific emphasis on knee; scores range from 1 (least strenuous activity) to 10 (high knee demanding activity on professional sports level).15
¶Patients with score at five years that was same as or higher than pre-injury score.
**Assesses anteroposterior laxity of knee at rest in semiflexed position; results range from 0 (normal laxity) to 3 (severely increased laxity); data include knees with normal laxity.
††95% confidence interval for percentage.
‡‡Assesses rotational stability of knee at rest; results range from 0 (normal stability) to 3 (severely increased instability); data include knees with normal stability.