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,*
From the School of Physical Therapy, Department of Surgery, Orthopaedic Division, University of Western Ontario, London, Ontario, Canada, Cape Breton Regional Hospital, Sydney, Nova Scotia, Canada, || Fowler Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, Canada, and ¶ University of Iowa Hospitals and Clinics, Iowa City, Iowa
* Address correspondence to Dianne Bryant, PhD, School of Physical Therapy, Faculty of Health Sciences, Department of Surgery, Orthopaedic Division, University of Western Ontario, Elborn College, Room 1438, London, ON, N6G 1H1 (e-mail: Dianne.Bryant{at}uwo.ca).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Study Design: Randomized controlled clinical trial; Level of evidence, 1.
Methods: One hundred consecutive patients were randomly assigned to arrows (n = 51) or sutures (n = 49). Sixty-five percent of patients (31 sutures, 34 arrows) underwent a concomitant anterior cruciate ligament reconstruction. A blinded research associate conducted assessments at 6 weeks and 3, 6, 12, and 24 months postoperatively. The primary outcome was retear rate. Secondary outcomes included the Western Ontario Meniscal Evaluation Tool, Anterior Cruciate Ligament Quality of Life Outcome Measure, and side-to-side comparisons of flexion and extension.
Results: At baseline, groups were similar in age, gender, time from injury to surgery, and length and location of tear. Mean follow-up was 28.0 ± 8.4 months. There were 22 failed meniscal repairs (11 in each group), which did not represent a significant difference in the rate of failure between groups (P = .92). The mean quality of life scores and side-to-side differences in extension and flexion measurements were not significantly different between groups. Two patients from the arrow group crossed over into the suture group at the time of surgery because of technical difficulties with the device, and in 3 instances, a single suture was needed to keep the tear reduced while arrows were introduced. Two patients required reoperation for removal of a prominent, subcutaneous arrow, and 1 patient in the suture group suffered a transient peroneal nerve palsy during revision suturing.
Conclusion: At intermediate follow-up, there were no statistically significant differences in measured outcomes between meniscal suturing and arrows. Longer term follow-up is necessary to identify differences between these 2 treatments, particularly to estimate the incidence of articular surface damage in patients whose meniscal tear was repaired using arrows.
Key Words: meniscal lesion • meniscal repair • arrow • inside-out suturing
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Techniques described for repair of the meniscus include both open and arthroscopic techniques using sutures and, more recently, bioabsorbable implants.2,23,25 Advantages of bioabsorbable implants include a less technically demanding repair and a lower risk of neurovascular injury. Experimental data assessing the biomechanical integrity of sutures compared with one of the first bioabsorbable implants, the Mensicus Arrow (Bionx, Blue Bell, Pa), have been conflicting. Albrecht-Olsen et al2 showed that a meniscal arrow had a pull-out strength comparable with that of Maxon-0 horizontal sutures, whereas Dervin et al9 found 2-0 Ethibond vertical loop sutures to have a significantly higher mean load to failure than that of meniscal arrows. In addition, Arnoczky and Lavagnino3 demonstrated that the arrow had significantly higher failure strength than did other meniscal repair devices and similar failure strength to 2-0 polydioxanone vertically oriented sutures, even after 24 weeks of hydrolysis using saline, antibiotics, antimycotics, and protease inhibitors. Results of preliminary clinical studies evaluating the performance of the meniscal arrow have been favorable. Kristensen et al15 reported that 15 of 17 menisci repaired using the meniscal arrow had healed at second-look arthroscopy. Hurel et al13 reported an 88% satisfactory outcome at 1 year using the bioabsorbable arrow. A nonrandomized cohort study comparing the success rate of 47 inside-out suture repairs and 98 all-inside repairs found no difference in rates of failure between groups. However, to date, there has not been a prospective randomized clinical trial comparing the failure rate of suturing to meniscal repair using bioabsorbable arrows.27 Therefore, the purpose of this study was to compare the effectiveness of vertical inside-out suturing and bioabsorbable arrows for meniscal repair.
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METHODS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Patients were not eligible if they had undergone a previous meniscal repair in the operative knee, had an unstable knee joint and were not undergoing concomitant ligament reconstruction, had active joint or systemic infection, or had a major medical illness that would preclude surgery. Other exclusions included those patients who were unwilling or unable to be followed according to study protocol for 2 years, including patients who had plans to move outside of the vicinity of the participating center; those who had a major psychiatric illness; those who were intellectually challenged; and those unable to speak or understand the English language (Figure 1
).
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Randomization
The randomization sequence was generated using a computer random-number generator using permuted block sizes of 4 and 6. Concealment of randomization was accomplished by using sequentially numbered opaque sealed envelopes, which were kept outside of the operating suite and accessed by the nursing staff only after a meniscal tear was identified as reparable according to the specifications of the eligibility criteria. Patients were stratified according to surgeon and according to whether they were undergoing concomitant ACL reconstruction at the time of meniscal repair (concomitant ACL reconstruction or isolated meniscal repair).
Intervention
For both procedures, synovial abrasion and debridement of scar tissue were carried out to promote vascular ingrowth before the repair.
Inside-out Suturing.
Either a posteromedial or posterolateral approach, depending on the location of the tear, was used to expose the joint capsule, and a spoon-shaped retractor was inserted to protect neurovascular structures during suture passing. A single lumen cannula was then used to pass 2-0 Ethibond sutures in a vertical fashion across the tear site. Sutures were spaced every 5 mm along the length of the tear. If vertical sutures were not possible, oblique or horizontal sutures were used.
Bioabsorbable Arrows.
An automatic or manual application device was used to insert arrows, depending on surgeon preference. Either 10-mm or 13-mm arrows were used and spaced 5 mm apart along the length of the tear.
Postoperative Rehabilitation
Patients who underwent an isolated meniscal repair had the knee locked in extension using a Zimmer splint for 3 weeks after surgery and were allowed protected weight-bearing (full weightbearing with the protection of crutches). After 3 weeks, weightbearing was as tolerated, and range of motion was unlimited. Patients were instructed to avoid squatting, pivoting, and twisting for a minimum of 6 months.
Patients who underwent a concomitant ACL reconstruction followed the standard ACL reconstruction rehabilitation protocol, which includes protected weightbearing until normal gait is regained with no restrictions on range of motion. In both groups, the supervising physical therapist was instructed to concentrate rehabilitation on regaining strength and sport-specific function where indicated.
Outcome Measures
The primary outcome measure was retear rate. Retear was determined by repeat arthroscopic evaluation of patients with follow-up for symptoms of persistent or new pain, catching, or locking that was possibly related to the meniscal repair.
Secondary outcomes included disease-specific quality of life measurement with the Anterior Cruciate Ligament Quality of Life Outcome Measure (ACL-QOL),19 Western Ontario Meniscal Evaluation Tool (WOMET),14 and range of motion (passive flexion and extension). We also recorded operative time, size and location of the meniscal tear, details of the repair, and any complications or adverse events at surgery or throughout the follow-up period.
The ACL-QOL is a validated, reliable, and responsive patient-based 32-item questionnaire (100-mm visual analog scale response format). This questionnaire inquires into the domains of symptoms/physical complaints, work-related concerns, recreational activities/sport participation/competition, lifestyle, and emotional well-being to provide a subjective measure of quality of life for patients with chronic ACL deficiency. A patient’s score is determined by converting the mean of each of the domains to a total mean score of 100, with 100% being the best possible score.
The WOMET is a validated, reliable, and responsive patient-based 16-item questionnaire (100-mm visual analog scale response format), which inquires into the domains of physical symptoms, sports/recreation/work/lifestyle, and emotional well-being. This questionnaire provides a subjective measure of quality of life for patients with meniscal injury. A patient’s score is determined by calculating the sum of each domain to attain a total score out of 1600, which is then converted to a mean score of 100, with 100% being the best possible score.
Passive flexion and passive extension were measured by the research assistant for both knees with a standard universal goniometer, which has been shown to have good intraobserver and interobserver reliability in the knee joint.6
For the suture group, operative time was recorded as the time from the meniscal repair incision to wound closure completion. For the arrows group, operative time was recorded from the introduction of the first arrow into the knee joint to when the last arrow was secured to the meniscus and the insertion device was removed.
The location, length of tear, and number of sutures or arrows used were recorded on a study operative information form by the surgeon. The operative information form included an illustration of the meniscus, which the surgeon used to indicate tear location and device placement. In addition, each patient’s arthroscopic evaluation of the torn meniscus and the subsequent repair were videotaped from within the knee joint for further documentation.
Finally, any complications during the meniscal repair procedure and any adverse events occurring after the procedure as well as any resulting treatment were documented on an adverse events form.
All patients were assessed before surgical intervention (baseline), at 6 weeks, and 3, 6, 12, and 24 months after surgery. The data collector was blinded to patient group assignment by having the patients wear opaque elastic stockings over the operative knee to cover incision scars. Because of differences in incision scars for arrows and sutures, it was impossible to blind the patient to group allocation.
Sample Size Calculation
The estimated sample size of 152 subjects was based on a 2-sided comparison of the difference (risk difference) in retear rates in patients undergoing meniscal repair using bioabsorbable arrows compared with patients undergoing meniscal repair inside-out suturing. We wanted 80% power to detect a 15% risk difference in favor of the inside-out suture group with 5% probability of making a type I (alpha) error (2-sided). The absolute risk of retear in patients undergoing meniscal repair using inside-out sutures was assumed to be 5%. As our recruitment was much slower than anticipated (4 years of recruiting), we decided to terminate recruitment at 100 patients.
Statistical Analysis
Data were analyzed using an intention-to-treat analysis in which patients were analyzed according to the group into which they were originally randomized. Patients who crossed over into the other group because of technical failure of the equipment at the time of surgery were analyzed in their original groups. If a patient required revision repair and a different repair technique was used to make the repair, the data were analyzed in the patient’s original group. Furthermore, the analyses included all patients randomized into the trial, regardless of compliance with study rehabilitation protocol.
For the primary outcome of retear rate, we calculated a relative risk with a 95% confidence interval (CI) around the estimate and provided a P value using the Fisher exact test. The secondary analyses of quality of life (ACL-QOL, WOMET) and range of motion involved the comparison of 2 independent continuous variables. We used an analysis of covariance in which the preoperative measurement was used as the covariate and the 24-month postoperative measure was used as the dependent variable.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Of the 100 eligible consenting patients, 49 were randomized to the inside-out suturing group, and 51 were randomized to the bioabsorbable meniscal arrows group. Sixty-four (64%) patients underwent meniscal repair on the right knee, and 86 (86%) patients had a repair of the medial meniscus. The mean follow-up was 28.0 ± 8.4 months (range, 9–46 months). Time to complete the repair for the sutures group (41.9 ± 21.0 minutes) was significantly longer than that for the arrows group (24.8 ± 16 minutes; P < .0001).
Patient Characteristics
Patients in the suturing group were similar to patients in the arrows group with respect to age, gender, proportion undergoing concomitant ACL reconstruction, and time from injury to surgery. In addition, subjects in each group had similar meniscal tears with respect to length and tear location on the meniscus, including anterior to posterior location and vascular zone (Table 1).
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Crossovers
There were 2 patients randomized to the arrow group who crossed over into the suture group at the time of surgery. In 1 case, the surgeon experienced technical difficulties with the device used for application of arrows. In the second case, the meniscal tear, which was completely displaced, could not be held reduced using arrows; therefore, this patient was crossed over into the suture group.
Retear Rate
There was no significant difference between the arrow group (n = 11) and the suture group (n = 11) for retears of the meniscus (relative risk, 0.96; 95% CI, 0.46–2.01; P = .92). Of the 11 patients who retore the meniscus in the arrow group, 5 patients underwent revision repair using sutures (2 patients later failed this re-repair; 1 patient underwent a subtotal meniscectomy, and 1 patient underwent a partial meniscectomy), and 6 patients underwent partial meniscectomy. Of note, there were 2 patients with clinical suspicion of a meniscal retear who refused further surgical intervention, 1 patient who tore her contralateral meniscus in the study knee. These patients are not counted in the analysis of patient retears.
Of the 11 patients who retore the meniscus in the suture group, 3 patients underwent revision repair using sutures (1 patient later failed this re-repair and required a partial meniscectomy), 7 patients underwent partial meniscectomy, and 1 patient underwent a subtotal meniscectomy. Of note, there was 1 additional patient who retore the same meniscus but in a different location. This patient is not counted in the analysis of patient retears.
It should be noted that 1 subject in the suture group retore his meniscus playing beach volleyball 2 weeks after repair (against protocol), and 1 patient retore his meniscus when he ruptured his ACL after returning to sport 8 months after meniscal repair. In addition, 1 subject in the arrows group, who was an elite soccer player, retore her meniscus and ruptured her ACL graft after return to sport 1 year after meniscal repair and ACL reconstruction (revision repair using sutures). These patients are counted in the analysis of retear rates.
Quality of Life
At 24 months after surgery, the adjusted mean score on the ACL-QOL for the arrows group was 67.5% (95% CI, 58.2%–76.8%) and for the suture group was 69.0% (95% CI, 60.5%–77.5%). The difference between groups was not statistically significant (1.6%; 95% CI, –11.3% to 14.4%; P = .81) (Figure 2). Findings were similar for the WOMET; at 24 months after surgery, the adjusted mean score on the WOMET for the arrows group was 67.3% (95% CI, 58.5–76.1) and for the sutures group was 69.7% (95% CI, 60.4–79.1). The difference between groups was not statistically significant (2.4%; 95% CI, –10.5 to 15.4; P = .71) (Figure 3). For both the suture and the arrow group, patients’ scores improved significantly from baseline to the 24-month follow-up (P < .0001). This finding was consistent across instruments.
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The mean postoperative passive extension (adjusted for preoperative passive extension) for the arrows group was 4.9° of hyperextension (95% CI, 3.2°–6.6°) and for the sutures group was 3.9° of hyperextension (95% CI, 2.0°–5.7°). The difference between groups (arrows – sutures) was not statistically significant (–1.0°; 95% CI, –3.6° to 1.5°; P = .13) (Figure 4). For both the suture and the arrow group, patients’ passive extension improved significantly from baseline to the 2-year follow-up (P < .01).
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Flexion.
Preoperatively, the mean passive flexion for the operative knee was 129° ± 14° in the arrows group and 132.7° ± 14° in the sutures group. At 2 years after surgery, the mean passive flexion for the operative knee was 140.6° ± 10.4° in the arrows group and 144.2° ± 9.9° in the sutures group.
The mean postoperative passive flexion (adjusted for preoperative passive flexion) for the arrows group was 141.3° (95% CI, 137.9°–144.9°) and for the sutures group was 143.4° (95% CI, 139.7°–147.0°). The difference between groups (arrows – sutures) was not statistically significant (–2.0°; 95% CI, –7.1° to 3.0°; P = .42) (Figure 5). For both the suture and the arrow group, patients’ passive extension improved significantly from baseline to the 2-year follow-up (P < .0001).
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Complications and Adverse Events
There were 3 patients with a prominent arrow that elicited pain on palpation and protruded into the subcutaneous tissue at the medial joint line. One patient elected to have the arrow removed through an incision made over the prominence, and the other 2 patients elected to wait for the arrow to absorb.
One patient who was allocated to the suture group, a 15-year-old female patient, continued to have symptoms of meniscal injury after the repair and subsequently underwent a second meniscal repair, which also failed. After a second revision meniscal repair, also using sutures, the patient was noted to have a transient peroneal nerve injury causing a foot drop. Electromyography testing confirmed the clinical diagnosis. The patient was treated with a drop-foot brace, and the injury spontaneously resolved over the following year.
In addition, 1 patient (arrow group) required debridement of an unrelated radial tear; 1 patient (arrow group) who had undergone a concomitant ACL reconstruction required debridement of a cyclops lesion 1 year after surgery, although the meniscus was completely healed; 1 patient (arrow group) required a revision ACL reconstruction (meniscal repair was noted to be healed at the time of revision); and 1 patient (arrow group) ruptured her contralateral ACL 2 years after ACL reconstruction and meniscal repair. She had no clinical symptoms of meniscal injury in either knee.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Despite the comparable success rate between these 2 methods of repair, there were 34 patients who consented to participate in this study who could not be randomized because the surgeon thought that there was an indication for 1 repair method over the other. This suggests that although arrows and sutures offer similar chances of successful repair, there is still a need for both methods of repair depending on tear location.
The operative time required for sutures was significantly greater than that required for repair using arrows. Similarly, Albrecht-Olsen et al1 found the operative time using arrows to be half that using sutures. The authors of the present study concede the use of sutures does require the presence of an experienced assistant during the meniscal repair. Similarly, in cases in which the surgeon encounters a reparable meniscal tear but is not comfortable using sutures, arrows offer the possibility of a successful repair, which is a more favorable alternative to excising the damaged meniscal tissue, as may have been done in the past. The importance of maintenance of healthy meniscal tissue to preserve long-term function of the knee cannot be overemphasized as there is sufficient evidence that meniscectomy leads to early arthritic changes.7
All-inside devices play an important role in the repair of very posterior meniscal tears. The use of sutures in this setting is difficult because of close proximity to neurovascular structures and the necessity of the suture needle to pass front to back nearing these structures. Arrows may well be used in combination with sutures when there is a very large meniscal tear that extends from the anterior to posterior direction.
Worth noting, however, is that there were 3 patients who had a palpable meniscal arrow protruding into the subcutaneous tissue from the medial joint line. Only 1 of these patients elected to return to the operating room for removal of the implant. Because of the bioabsorbable nature of the arrow, spontaneous resolution of symptoms was possible in the other 2 patients over several months. There are several reasons that this may occur. First, the implant may be placed more peripherally than originally intended. Second, the arrow may be inappropriately long, and third, the head of the arrow may separate from the shaft, allowing migration into the subcutaneous tissue. Before commencement of the study, the authors noted that the occurrence of protruding arrows was most common when repair was done using the 16-mm arrow, as compared with repairs using the 10-mm or 13-mm implants. For this reason, there were no 16-mm arrows used in this study.
For similar reasons, the authors are of the opinion that arrows should not be used for fixation of tears at the meniscosynovial junction. In this setting, the arrow crosses the tear site and has the potential to penetrate through the capsule, perhaps piercing ligament, tendon, or subcutaneous tissue. In addition, the anatomy of the joint at the meniscosynovial junction does not provide adequate tissue for the barbs on the shaft of the meniscal arrow to capture to provide a stable repair. Oliverson and Lintner21 published 5 cases of meniscal repairs using arrows in which the implants were prominent within the subcutaneous tissue and symptomatic for patients. Because of this danger, a meniscosynovial tear is best repaired using sutures. In this manner, the capsule is exposed and the sutures visualized as they pass through the capsule, leaving other structures uninvolved.
An additional concern raised in the prestudy trial of the arrow was gouging of articular cartilage. Before commencement of the study, 2 patients were observed to have significant loss of articular cartilage in the region overlying the arrow. This finding has been documented previously in the literature.12,16,24,26 Of interest, an in vitro study conducted by Becker et al4 showed that meniscofemoral stress in articular cartilage does not increase dramatically in the area overlying bioabsorbable implants for meniscal repair. For this reason, in particular, we recommend that surgeons using the meniscal arrow ensure that the head of the arrow does not sit prominently above the meniscal surface; it should almost be embedded in the tissue. The authors found this most difficult to attain in the more anterior portions of the tear. In this study, 1 patient who underwent arthroscopic evaluation of the knee for residual pain 2 years after surgery was noted to have a lesion in the articular cartilage potentially caused by the head of the arrow. This lesion was located on the very edge of the surface of the articular cartilage and was not on the weight-bearing surface. In this study, patients underwent repeat arthroscopy only if they had clinical symptoms after the initial repair. It is possible that articular cartilage lesions remain clinically silent and thus would have gone undetected in this study. It remains to be seen whether further patients in the arrow group will experience similar and progressive cartilage loss over a longer time period.
A limitation of this study is that despite the finding that there is no statistically significant difference between groups for retear rates, range of motion, and quality of life, the 95% CI around the between-groups difference for each of these outcomes did contain differences that are clinically important. Thus, our study cannot rule out with complete certainty the possibility that important clinical differences do exist between these treatment groups.
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CONCLUSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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ACKNOWLEDGMENTS |
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FOOTNOTES |
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REFERENCES |
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Deceased. 