Table 2.
Characteristics of Included Studies
| Author, Year | Bottoni et al., 201520 | Sun et al., 200923 | Sun et al., 201124 | Tian et al., 201619 | Li et al., 201522 | Jia and Sun, 201521 |
|---|---|---|---|---|---|---|
| Country | USA | China | China | China | China | China |
| Sponsor | Arthrex, and the Musculoskeletal Transplant Foundation | Supported by Natural Science Foundation of China Grant no. 2004GG2202034 | Research funding was provided by the Key Project of the Provincial Science Foundation of Shandong |
NR | NR | Nil |
| Interventions/products | Fresh-frozen, nonirradiated tibialis posterior tendon allograft | Fresh frozen, nonirradiated BPTB hemi-allograft |
Fresh-frozen, nonirradiated hamstring tendon allograft | Fresh-frozen, irradiated hamstring tendon allograft | 4-stranded, y-irradiated tibialis anterior tendon allograft | Bone-patellar tendon-bone allograft |
| Comparator | 4-stranded hamstring autograft | BPTB autograft | 4-stranded hamstring tendon autograft | Hamstring tendon autograft | 4-stranded gracilis and semitendinosus tendon autograft Hybrid graft (y-irradiated tibialis anterior tendon allograft and semitendinosus tendon autograft) |
Hamstring autograft |
| Surgical procedure | ACLR (not further specified) | Arthroscopic ACLR |
Arthroscopic ACLR |
Arthroscopic anatomic double-bundle ACLR | ACLR (not further specified) | Arthroscopic ACLR |
| Study design | RCT | RCT | RCT | RCT | RCT | RCT |
| Number of patients∗ | 99 patients (100 knees) 50 vs 50 (knees) |
172† 86 vs 86 |
208‡ 104 vs 104 |
107§ 53 vs 54 |
102‖ 34 vs 34 vs 34 |
106¶ 53 vs 53 |
| Inclusion criteria | Patients 18 years of age or older with symptomatic ACL deficiency, confirmed by MRI |
Only primary unilateral reconstructions of the ACL were included in the study.# Patients with minor medial collateral ligament sprains (lower than grade II), previous diagnostic arthroscopy, or meniscal tears were not excluded from the study. |
Only primary unilateral reconstructions of the ACL were included in the study.# No previous injury or surgery on the affected knee, No multiple ligamentous injuries or malalignment, and Ability to complete the study protocol. Patients with minor medial collateral sprains (<grade 2), meniscal tears and or previous diagnostic arthroscopes were not excluded. |
Patients with acute or chronic ACL ruptures Only primary unilateral reconstructions of the ACL were included in the study.# |
Unilateral ACL rupture verified clinically by positive Lachman test and positive pivot shift test findings. All patients had undergone a preoperative MRI scan to confirm the ACL rupture. All patients with normal preoperative CRP (<10 mg/L) and ESR (≤15 mm/h) values were included. |
Diagnosis with ACL tear by physical examination and MRI, normal alignment, normal contralateral knee, and willingness to join the rehabilitation program |
| Exclusion criteria | Multiligamentous injuries (concomitant grade I or II medial collateral ligament injuries were not excluded), Previous knee ligament surgery (previous knee arthroscopic surgery was not excluded), and Time remaining on the island of less than 6 months |
Patients were excluded from the study if they had had a previous injury to or surgery on the affected knee; multiple ligamentous injuries, or malalignment; or if they lacked the ability to complete the study protocol. Patients undergoing revision reconstruction and those with associated injuries of the posterior cruciate ligament or posterolateral corner or with deficiency or reconstruction of the ACL in the contralateral knee were also excluded. |
Revision reconstruction and patients with associated injuries of the posterior cruciate ligament or the posterolateral corner, with deficiency, or a reconstruction of the ACL in the contralateral knee were excluded. | Patients were excluded if they had a previous injury or surgery on the affected knee, had open physes present, had severe arthritic changes in the knee, had multiple ligamentous injuries, had malalignment, lacked the ability to complete the study protocol, a revision reconstruction, associated injuries of the posterolateral corner, and deficiency or reconstruction of the ACL in the contralateral knee. |
Combined multiple-ligament injuries Previous ACL surgery Contralateral knee ligament injury, Radiographically verified osteoarthritis Patients with pre-existing metabolic pathologies such as diabetes mellitus or uremia were excluded from the study. Those patients who could not finish the minimum clinical follow-up period of 5 years were also excluded. |
NR |
| Rehabilitation (before or after ACLR) | Physical therapy∗∗ (standardized protocol) | Physical therapy∗∗ (same protocol) | Physical therapy∗∗ (same protocol) | Physical therapy∗∗ (same protocol) | Physical therapy∗∗ (standardized protocol) | Physical therapy∗∗ (same program) |
| Age of patients, y, mean ± SD (range) | 29.2 ± 5.5 (20.7-41.5) vs 28.9 ± 5.8 (20.6-42.5) | 32.8 ±7.1 (19-65) vs 31.7 ±6.3 (20-54)†† | 31.2 ± 8.3 (18-59) vs 29.6 ±6.9 (19-56)†† | 28.6 ±7.2 (18-50) vs 29.2 ± 6.9 (18-55)†† | 30.5 ±6.1 vs 29.8 ±7.9 vs 31.6 ±8.2††,‡‡ | 28 vs 31§§ |
| Sex, n female (%) | 6 (12.2) vs 7 (14.6) | 17 (21.3) vs 15 (20) | 17 (17.9) vs 20 (22) | 9 (20.9) vs 8 (20) | 17 (53.1) vs 15 (46.9) vs 13 (41.9) | 27 (50.9) vs 25 (47.2) |
| Further relevant patient characteristics at baseline and cointerventions | 95% of patients were in the military (active-duty). Concomitant meniscal and chondral pathologic abnormalities, microfracture, and meniscal repair performed at the time of reconstruction were similar in both groups. No statistically significant differences were found when comparing the respective baseline characteristics between allograft and autograft groups, except for lateral compartment: grade 0: 43 (87.8%) vs 35 (72.9%); grade 1: 3 (6.1%) vs 3 (6.3%); grade 2: 1 (2%) vs 6 (12.5%); grade 3: 2 (4.1%) vs 0 (0%); grade 4: 0 (0%) vs 4 (8.3%). Difference of LC category was s.s. with P = .034. |
No statistically significant differences between treatment groups when considering arthroscopic findings and treatments at time of ACLR No. of patients with normal meniscus (no treatment of meniscal tears at time of ACL reconstruction): 36/80 patients (45%) vs 36/76 patients (47%) |
No statistically significant differences between treatment groups when considering arthroscopic findings and treatments at time of ACLR No. of patients with normal meniscus (no treatment of meniscal tears at ACL reconstruction): 48/95 patients (50.5%) vs 45/91 patients (49.5%) |
No statistically significant differences between treatment groups when considering arthroscopic findings and treatments at time of ACLR No. of patients with normal meniscus (no treatment of meniscal tears at ACL reconstruction): 18/43 patients (41.9%) vs 16/40 patients (40.0%) |
No statistically significant differences when considering associated injuries and treatments before ACLR No. of patients with no treatment of meniscal tears: 3/32 patients (9.4%) vs 6/32 patients (18.8%) vs 7/31 patients (22.6%) |
Baseline characteristics insufficiently described |
| Mean follow-up, y | 10.5, range: 10-11 | 5.6, range: 4-8 | 7.8, range: 6-10 7.9 (SD 1.1) vs 7.6 (SD 0.9) |
6.9, range: 5.5-8 6.8 (SD 0.8) vs 7 (SD 0.7) |
5.9 (overall mean), range: 5-7 6.1 (SD 0.3) vs 5.8 (SD: 0.9) vs 5.9, SD 0.6 |
6.75, range: 2.33-7.16 |
| Loss to follow-up, n (%)‖‖ | Overall: 3 (3) 1 vs 2¶¶ |
Overall: 16 (9.3) 6 (6.9) vs 10 (11.6) |
Overall: 22 (10.6) 9 (8.7) vs 13 (12.5) |
Overall: 24 (22.4) 10 (18.9) vs 14 (25.9) |
Overall: 7 (6.8) 2 (5.9) vs 2 (5.9) vs 3 (8.8) | Overall: 0 (0) 0 (0) vs 0 (0) |
| Patients included in analysis, n | 49 vs 48 (knees)## | 80 vs 76 | 95 vs 91 | 43 vs 40 | 32 vs 32 vs 31 | 53 vs 53 |
NOTE. Source: Goetz and de Villiers.12
ACL, anterior cruciate ligament; ACLR, anterior cruciate ligament reconstruction; BPTB, bone–patellar tendon–bone; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; LC, lateral compartment; MRI, magnetic resonance imaging; NR, not reported; RCT, randomized controlled trial; SD, standard deviation; s.s., statistically significant.
At time of randomization.
218 patients underwent ACL reconstruction. Of those, 195 patients were eligible to participate in the study. 172 patients provided written, informed consent and were randomized to different treatment groups.
256 patients were assessed for eligibility, of whom 208 were randomized to the different treatment groups.
121 patients were assessed for eligibility, of whom 107 were eligible and randomized to the different treatment groups.
281 patients were assessed for eligibility, of whom 102 patients were randomized to the different treatment groups.
122 patients were assessed for eligibility, of whom 106 patients were randomized to the different treatment groups.
All patients had an MRI scan obtained preoperatively to exclude combined, complicated ligament injuries to their knees.
Physical therapy may have included, but was not limited to, the following: preoperative therapy to restore full knee range, normal gait, and eliminate knee swelling; postoperative: Full extension range of motion, strengthening exercises, range of motion brace (for 4 weeks postsurgery), and a functional brace for sport activities (for 1-2 years after surgery). Adaptations for range of motion restriction and weightbearing status applied, with accompanying meniscal and chondral surgery. 2 studies explicitly reported that physical therapy provided outside of the institution may have varied and may have been a factor that influenced the outcomes.
The study only described information on the age and sex of the patients who were analyzed (as opposed to the number of patients who were originally randomized). Therefore, the denominator used to calculate the percentages is the number of patients analyzed in the respective treatment group.
The range of the variable age was not reported in the study.
SD and range were not reported.
Due to the fact that calculating the loss to follow-up is sometimes confused in clinical studies, the loss to FU was calculated by the review authors using consistent criteria: The follow-up rate was calculated using the number of randomised patients as the denominator and the number of patients analyzed as the numerator. The difference between randomised and analyzed patients was therefore considered to be patients lost to FU.46
The review authors judged it to be spurious that the investigators switched constantly between knees and patients when reporting characteristics of patients and results. Given that it was only reported that 50 knees were randomised in two groups, the percentage for the loss to FU in each group was not estimable. Of the patients lost to follow-up, 2 were deceased, and 1 patient was lost to follow-up for other reasons.
It was unclear to the review authors whether the presented results refer to 97 knees or patients, because the study did not clearly report it. Given that 3 patients were lost to follow-up, 97 knees must have been considered in the analysis.