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Increased benefit seen after cervical TDA compared to fusion in well-selected patients

Cervical total disc arthroplasty and anterior interbody fusion provided effective pain reduction for patients.

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Randomized controlled trials have known limitations regarding their external validity, but the results of a recently presented award-winning observational study that compared patient-reported outcomes after total disc arthroplasty to those of anterior cervical interbody fusion showed both groups’ results were similar to those in previously published randomized controlled trials.

Investigators performed three separate analyses using data in the Spine Tango Registry, an international spine registry, to compare cervical total disc arthroplasty (TDA) to cervical anterior interbody fusion (AIF). Patients experienced substantial pain reduction from both treatments, but the patients treated with TDA experienced slightly greater benefits, according to Max Aebi, MD, DHC, FRCSC, one of the investigators.

RCTs vs the registry

Emin Aghayev, MD, presented the results of the study at the North American Spine Society Annual Meeting, where it was recognized with an Outstanding Paper Award.

“It is interesting to note that the results in this large multinational registry are not relevantly different when cervical TDA and AIF are compared to each other, specifically in patients who are usually not part of an randomized controlled trial [RCT]. TDA seems to do only slightly better when compared to AIF in very select patients (like in RCTs), which corresponds pretty well to the Cochrane review. This review is entirely based on RCTs,” Aebi, told Spine Surgery Today.

Aebi and colleagues included 987 patients with cervical degenerative discs or cervical disc herniations treated with single-level TDA or AIF. The investigators used neck and arm pain relief and Core Outcome Measures Index (COMI) scores as the primary outcome measures. They evaluated neck and arm pain and COMI scores at baseline and later evaluated them at 3-months postoperatively, minimum.

Three analyses done

The investigators performed three separate analyses to compare the treatments. The first mimicked an RCT setting and included a 1:1 matched analysis done in 739 patients. The goal was to see if the short-term outcomes were similar between the registry data and the RCT data, Aghayev noted in his presentation.

The second study included atypical patients. It was an analysis outside of the classic RCT spectrum performed on 248 patients. Investigators performed a multivariate linear regression analysis on the outcomes, Aghayev said.

The final analysis consisted of a subgroup examination of 149 patients with more than 2 years of follow-up.

No difference in outcomes

In the first study, investigators found 190 pairs of patients with an average follow-up of 17 months. Small, but statistically significant differences in outcome were observed in favor of TDA, which are potentially relevant, according to Aghayev.

In the second study, there were no statistically significant differences in outcomes for the atypical RCT patients in that all the patients studied experienced similar outcomes in postoperative neck and arm pain and COMI scores.

In the third study, there were no differences in outcomes at long-term follow-up for patients in either cohort.

“The real-life, as well as the long-term perspectives, are absolutely essential when it comes to judging implant-based therapies. On the other hand, the clinical results in the large international registry are similar between cervical TDA and AIF in patients who are typically excluded from RCTs, which was not reported so far. In well-selected patients, TDA appears to be slightly clinically beneficial compared to AIF in terms of substantial pain reduction and COMI score improvement,” Aghayev told Spine Surgery Today. – by Robert Linnehan

• Reference:
• Staub LP, et al. Total disc arthroplasty vs. anterior cervical interbody fusion: Use of the Spine Tango Registry to supplement the evidence from RCTs. Presented at: North American Spine Society Annual Meeting; Oct. 14-17, 2015; Chicago.

• For more information:
• Max Aebi, MD, DHC, FRCSC, can be reached at Department of Orthopaedic Surgery, Salem Spital, Schänzlistrasse 39, Bern 3025, Switzerland; email: max.aebi@memcenter.unibe.ch.
• Emin Aghayev, MD, can be reached at Institute for Social and Preventive Medicine, Finkenhubelweg 11, 30142 Bern, Switzerland; email: emin.aghayev@ispm.unibe.ch.

Disclosures: Aebi and Aghayev report no relevant financial disclosures.