Difference in Early Results Between Sub-Acute and Delayed ACL reconstruction: A Randomized Controlled Trial
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This randomized controlled trial compared outcomes of sub-acute ACL reconstruction (within 8 days of injury) versus delayed ACL reconstruction (6-10 weeks post-injury). At 3 months, there were no differences in range of motion between groups. At 6 months, the sub-acute group showed less thigh muscle atrophy and better functional strength on hop tests, though isokinetic strength was similar. Both groups improved significantly on KOOS scores after reconstruction, with no differences between groups. The study suggests sub-acute ACL reconstruction is safe and may help preserve strength compared to delayed reconstruction.
Difference in Early Results Between Sub-Acute and Delayed ACL reconstruction: A Randomized Controlled Trial
- 1. Differences in Early Results Between Sub-Acute and Delayed ACL Reconstruction: A Randomized Controlled Trial Henrik Illerström*, Björn Barenius*, Karl Eriksson* *Dep.of Orthopaedics, Institution for clinical studies and education, Södersjukhuset, Karolinska Institutet,11883 Stockholm
- 2. Disclosure The authors have no financial conflicts to disclose
- 3. The Study at a glance Background: Does acute ACL reconstruction lead to arthrofibrosis as we have been told? Aim: Is it safe to do a sub-acute arthroscopic ACL reconstruction? Method: Patients with acute ACL ruptures and Tegner > 6 were randomized between sub-acute and delayed reconstruction. Results: 70 patients were included. 64 (91%) patients were assessed at three months and 67 (96%) at six months. At three months there were no differences between the groups in ROM neither in total ROM, extension or flexion. At six months there were signs of more functional strength in the acute group. Conclusion: Arthroscopic ACL reconstruction is safe to perform in a sub- acute setting in an active population.
- 4. Introduction Numerous reports of arthrofibrosis after early ACL reconstruction in the 90’s1 led to a paradigm shift and the acute surgery after knee injuries in the 30’s-50’s were abandoned and the principal most surgeons today would prefer was adopted: No ACL reconstruction before ROM is normalised But are the risks of acute surgery still valid with the arthroscopic surgery of today? There are indications that this is not true2. And are there any benefits for the patient with an early ACL reconstruction? The aim of this study was to investigate if it is safe to reconstruct the ACL within the first week after the injury. And to observe if there are differences in outcome after ACL reconstruction depending on the time between injury and reconstruction and additional injuries.
- 5. Method Study design: A randomized controlled trial with primary endpoint ROM at 3 months. Randomization between sub-acute ACL reconstruction (within 8 days after the injury) and delayed ACL reconstruction (after normalized ROM, 6-10 weeks after the injury) According to the power analysis 64 patients was needed to find a difference of 5 degrees in ROM between the groups. Inclusion criteria: Primary ACL injury in knee healthy person between 18-40 years of age with Tegner activity of at least 6 and a conviction of a need for an ACL reconstruction to continue their preferred activity level. No additional injuries on MRI indicating a need for an acute procedure. Surgical method: One center, four surgeons, Arthroscopic ACL reconstruction with Endobutton® fixation in femur and metal interference screw in tibia. Single bundle quadrupled semitendinosus tendon graft, if < 65mm length gracilis tendon added to graft. Free periostal flap attached to graft at femur aperture. Rehabilitation: One center, Full weight-bearing after surgery, open chain exercises allowed after 6 weeks, running after 14 weeks and return to sport if Biodex®3 showed > 90% strength of CL leg.
- 6. Results: Descriptives Group descriptives Acute Reconstructed Delayed Reconstructed Sign Male / Female 22 / 10 24 / 11 NS Age at injury y(SD) 27.7 (6.5) 26.1 (5.7) NS Days Inj.=>Surg. d(SD) 6.2 (5.6) 53.9 (10.0) <0.001 Additional injury n (%) 21 (66%) 15 (47%) NS Medial Meniscus n (%) 7 22% 2 6% NS Lateral Meniscus n (%) 13 41% 10 31% NS Sutures n (%) 3 9% 1 3% NS Cartilage inj. n (%) 10 31% 4 13% NS Semitendinosus n (%) 26 81% 26 81% NS OP Time min(SD) 93 (20) 83 (18) NS Excluded before ACL reconstruction (n=1) 1 delayed terminated study due to waiting time Received allocated intervention 34 Acute reconstruction (AR) Received allocated intervention 35 Delayed reconstruction (DR) 1 patient excluded, could not follow protocol Lost to follow-up ? Allocation6monthFU Analysed 97%, (n=33) Acute reconstruction (AR)Analysis Analysed 100%, (n=35) Delayed reconstruction (DR) 70 patients Accepted 69 patients Randomised 2088 patients were assessed in clinic during the study period, 2018 were excluded, due to: 1168 (58%) No ACL rupture 262 (13%) Age outside study crit. 200 (10%) Combined ACL and coll. lig. damage outside study crit. 79 (4%) Missed potential cases (patient and or hospital related) 59 (2.9%) Chronic ACL rupture 55 (2.7%) Not possible to reconstruct inside study time limits 52 (2.6%) Meniscus injury indicating need for acute surgery 39 (1.9%) Earlier ACL/trauma to knee w. unresolved symtoms 32 (1.6%) To low activity level 30 (1.5%) Conservative treatment indicated 24 (1.2%) Contralateral ACL recon 10 (.5%) Declined to participate 4 (.2%) Wounds in surgical field 3 (.1%) Not habitant of Stockholm 1 Insufficient language skills Out of 2088 assessed patients, all with an acute knee injury assessed at our knee clinic, 70 patients were included according to our strict criteria. There were no significant differences of additional injuries or the need for adding the Gracilis tendon to the grafts between the groups. 70 % were males. One patient dropped out early from the delayed group. “Could not wait”. A second patient dropped out late due to inability to comply with rehab and study protocol.
- 7. Primary endpoint at 3 months At 3 months, 64/70 (91% ) patients were assessed with a goniometer by a non blinded physiotherapist. The contralateral leg was used as reference. There were no significant difference in either extension, flexion or total ROM between groups. Primary endpoint at 3 months 64/70 (91% ) pat assessed at by non blinded physio. No difference in any ROM measure ROM degrees At 3 months po Acute Mean (SD) Delayed Mean (SD) Sign Active Extension +1 (2) 0 (1) NS Active Flexion 139 (7) 141 (7) NS Loss of extension vs. CL 3 (4) 2 (3) NS Loss of flexion vs. CL 6 (7) 6 (7) NS Total ROM inj. limb 140 (8) 141 (8) NS Total ROM loss vs. CL 10 (9) 8 (7) NS
- 8. Laxity 6 months 1+ 2 Not possible to perform 1 IKDC objective(%) Acute Delayed A 10 16 B 74 55 C 13 26 D 3 3 Clinical assessment at 6 month Tegner Activity Acute Median(range) Delayed Median(range) Sign Pre-injury 8 (6 - 10) 9 (5 - 10) NS At inclusion 0 (0 – 6)* 0 (0) 0.001 At 6 months 4 (1 – 9) 4 (0 – 9) NS *At inclusion 8 Tegner 1, and one Tegner 6 in Acute grp. Measured with Rollimeter4 and Pivot shift test – At 6 months no significant difference were found between the groups. Function 6 months Activity 6 months IKDC Objective Score5 for knee function. After 6 months a majority of patients scored A or B, with no significant difference between groups. Before injury the Tegner activity level6 was median 8-9 a high recreational level, after 6 months the median patient had 4 correlating to running 2-3 times/w. No significant difference between groups were found.
- 9. Functional Strength at 6 months Acute Delayed Sign. Thigh circumference 0.9 (1.0) 1.5 (1.2) 0.04 (cm deficit vs CL) One leg hop difference7 0.009 ≥90% 15 6 76-89% 11 10 50-75% 8 13 <50% 0 7 Biodex® Peak Torque deficit vs CL. Ext. isokinetic 60 deg/s 27 (15) 34 (18) NS Flex. isokinetic 60 deg/s 14 (13) 17 (16) NS Compared to contralateral leg, the acute group had significantly less muscle atrophy of the thigh muscles and more patients in the acute group passed or were close to passing the one leg hop test. However there were no difference in strength between the groups in the Biodex® test.
- 10. KOOS preinjury 0 10 20 30 40 50 60 70 80 90 100 Pain Symptoms ADL SP/Rec QoL Acute before inj Delayed before inj KOOS after the injury 0 10 20 30 40 50 60 70 80 90 100 Pain Symptoms ADL SP/Rec QoL Acute before inj Delayed before inj Acute after inj Delayed after inj KOOS 6 months after reconstruction 0 10 20 30 40 50 60 70 80 90 100 Pain Symptoms ADL SP/Rec QoL Acute before inj Delayed before inj Acute 6 mo Delayed 6 mo Acute after inj Delayed after inj As seen in the diagram below to the left, the patients were healthy according to KOOS8 before the injury. A drastic decrease in the KOOS was seen after the injury (diagram below to the right). The KOOS six months after the reconstruction (diagram to the right) show a major increase in the health related quality of life compared to before the surgery, but with major differences compared to pre-injury. In all diagrams red lines for the acute group and blue for the delayed, there were no significant difference between groups. KOOS
- 11. How is your knee working? Weekly SMS survey for the first 3 months after the reconstruction. The diagram below show the mean results from the SMS-survey, red lines for the acute group and blue for the delayed. The error bars indicate one standard deviation. Ten was defined as no knee function and 0 normal function. There was no significant difference between the groups at any time-point.How is your knee working? SMS survey weekly for first 3 mo. 0 1 2 3 4 5 6 7 8 9 10 w1 w2 w3 w4 w5 w6 w7 w8 w9 w10 w11 w12 Kneefunction from no function "10" to normal "0" Acute reconstruction Delayed reconstruction No sign. Diff. any week
- 12. Discussion • The results of this study suggest that there is not an increased risk for arthrofibrosis after an acute ACL-reconstruction. • For patients with high functional demands, the results suggest that it is a possible to preserve muscular and functional strength with an acute ACL-reconstruction, thus speeding up the rehab process and decrease the time before the return to a desired activity level. • The results of this study suggests that the time spent on rehab before the reconstruction is not as useful as the rehab after the surgery. With an acute reconstruction the time between injury and recovery after the reconstruction can be minimized.
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