Physical Therapy Noninferior to Surgery for Some Meniscal Tears

Diana Phillips

October 04, 2018

Physical therapy appears to be nearly as effective as early arthroscopic surgery for treating nonobstructive meniscal tears in middle-aged to older adults, a study has shown.

In a randomized controlled trial, patients with degenerative, nonobstructive meniscus tears assigned to a structured program of physical therapy (PT) had similar patient-reported knee function as patients who underwent arthroscopic partial meniscectomy (APM) during a 2-year period.

The findings "are consistent with current consensus that APM should not be the first treatment in middle-aged and older patients with meniscal tears," the investigators write.

Victor A. van de Graaf, MD, from the Department of Orthopedic Surgery, Joint Research, OLVG Oosterpark Hospital, Amsterdam, the Netherlands, and colleagues published their findings online October 2 in JAMA.

The authors of an accompanying editorial agree that the findings provide additional support for a structured, nonoperative treatment approach to managing this knee condition. They caution, however, that changing clinical practice may require the various professionals involved in meniscus tear management to develop mutually agreeable evidence-based treatment guidelines. These include orthopedic surgeons, physiatrists, physical therapists, professional organizations, and insurance companies.

To evaluate the relative effectiveness of PT and APM in this study, the investigators enrolled 321 patients aged 45 to 70 years with degenerative meniscus tears without knee locking, instability, or severe osteoarthritis. Of these, they randomly assigned 159 to receive APM within 4 weeks and 162 to receive a PT exercise protocol developed by a knee-specialized physical therapist. The PT protocol consisted of 16 half-hour sessions over the course of 8 weeks, beginning within 2 weeks of randomization. Surgery patients were only referred to PT if they did not recover as anticipated, and PT patients that did not attain the desired outcomes could extend their PT or elect APM.

The primary outcome measure was patient-reported knee function on the Subjective Knee Form of the International Knee Documentation Committee assessed from baseline and over the course of 24 months, with a noninferiority threshold of 8 points. The threshold was adopted from an earlier study that estimated the noninferiority margin from a more heterogeneous meniscus injury population "[b]ecause a minimal clinically important difference...for the [International Knee Documentation Committee] has not been defined in a population consisting only of patients with meniscal tears," according to the investigators.

During the 2-year follow-up, mean knee function scores improved by 26.2 points (from 44.8 points to 71.5 points) in the APM group and by 20.4 points (from 46.5 points to 67.7 points) in the PT group. The between-group difference in the primary mixed model analysis of the overall effect was 3.6 points (97.5% confidence interval [CI], −∞ to 6.5) in favor of APM, which met the noninferiority criteria.

Although the between-group differences at 3 months and 6 months also showed noninferiority of PT, the effects at 12 and 24 months did not, according to the authors. "Longer follow-up will provide more details on the effect of time on the between-group differences," they write.

Additional, exploratory outcomes included knee pain during weight bearing, general health, activity level, and osteoarthritis severity. The mixed-model analysis of the overall effects found a between-group difference of 5.9 mm (95% CI, 1.4-10.3; P = .01) in favor of APM for knee pain during weight bearing, 1.3 points (95% CI, −0.2 to 2.7; P = .08) in favor of APM for general health, no significant difference (0.04 points [95% CI, −0.3 to 0.2; P = .73) for activity level, and no significant difference for osteoarthritis progression (0.10 points more progression in the APM group; 95% CI, −0.05 to 0.26; P = .18).

Of the patients randomly assigned to PT, 29% underwent delayed APM, "demonstrating that not all patients initially treated with PT were satisfied with their results," the authors write. "The post-hoc exploratory findings on effect modification could guide future research on the characteristics of individuals who may be less likely to respond to PT to improve their treatment options and functional outcome."

On the basis of the study results, the authors state that PT may be considered an alternative to surgery for patients with nonobstructive meniscal tears.

The authors of the accompanying editorial, Laith Jazrawi, MD, Heather T. Gold, PhD, and Joseph D. Zuckerman, MD, from the Department of Orthopedic Surgery at New York University School of Medicine, New York City, question whether limitations posed by the study design compromise the relevance of the findings.

"The trial used a noninferiority trial design, which is appropriate because PT may have other advantages over APM, such as lower cost, noninvasive nature, and fewer adverse effects such as surgical complications. However, the choice of the noninferiority threshold, or margin, was suboptimal," they write, explaining that the threshold was estimated based on a "very different" patient group (older man age, multiple surgical procedure types) and shorter follow-up (preoperative and postoperative International Knee Documentation Committee score after 12 months vs 24 months).

"Given that the current randomized trial showed only a 5.8-point difference before and after surgery in the intention-to-treat, unadjusted analysis, the threshold deserves careful scrutiny and probably should have been lower to be more confident about noninferiority," the editorialists suggest. This limitation notwithstanding, they do agree that the findings provide further support for a structured nonoperative treatment approach for meniscal tears in the setting of degenerative OA. Further, they write, "[o]rthopedic surgeons should recognize the value of this nonoperative approach and incorporate it into their treatment approach with the expectation that many patients will be treated successfully."

The editorialists also agree with the need for evidence-based guidelines developed by a multidisciplinary consortium. "The guidelines should be focused on the best interests of the patients, rather than the clinicians, therapists, and other groups or entities who may gain from the different treatments for degenerative meniscal tears," they write.

This study was funded by the Netherlands Organization for Health Research and Development, Zilverenkruis Health Insurance, and the Foundation of Medical Research of the OLVG, Amsterdam. Several study authors disclose multiple financial relationships with several pharmaceutical, biomedical, and research organizations. For the full list of disclosures, please see the journal website. Gold serves as the president of the Society for Medical Decision Making. The remaining editorialists have disclosed no relevant financial relationships.

JAMA. Published online October 2, 2018. Article full text, Editorial extract

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