A Clinical Trial Evaluating a Total Disc Replacement in Patients with Cervical Disc Disease

2012 ◽  
Author(s):  
Scott Kitchell
Keyword(s):  
Clinical Trial ◽  
Total Disc Replacement ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Cervical Disc Disease ◽  
Disc Disease

ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease

2015 ◽  
Vol 97 (21) ◽  
pp. 1738-1747 ◽  
Author(s):  
Michael E. Janssen ◽  
Jack E. Zigler ◽  
Jeffrey M. Spivak ◽  
Rick B. Delamarter ◽  
Bruce V. Darden ◽  
...  
Keyword(s):  
Total Disc Replacement ◽  
Anterior Cervical Discectomy ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Cervical Discectomy ◽  
Single Level

Clinical outcomes with the Prestige II cervical disc: preliminary results from a prospective randomized clinical trial

2004 ◽  
Vol 17 (3) ◽  
pp. 1-43 ◽  
Author(s):  
Francois Porchet ◽  
Newton H. Metcalf
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Outcome Measures ◽  
Cervical Disc ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Prospective Randomized Clinical Trial ◽  
Treatment Groups ◽  
Preliminary Results ◽  
The Prestige

Object A prospective, randomized clinical trial was conducted to compare the Prestige II Cervical Disc with anterior decompression and fusion for the treatment of single-level degenerative disease. Standardized clinical outcome measures and radiographic examinations were used at prescribed postoperative intervals to compare the treatment groups. Methods Patients with symptomatic single-level cervical disc disease who met the inclusion/exclusion criteria defined in the protocol were randomized to receive the Prestige II disc or iliac crest autograft fusion. All patients underwent a standardized neurological and radiographic examination and completed outcomes questionnaires (Neck Disability Index and Short Form–36) preoperatively and at each postoperative interval (6 weeks and 3, 6, 12, and 24 months). Two independent radiologists reviewed all x-ray films and assessed motion at the treated level and adjacent segments. Standard statistical methods were used to compare all outcome measures. Preliminary results in 55 patients enrolled in the study are presented. Several patients have reached the final (24-month) follow-up interval. Clinical and radiographic results are encouraging, with significant improvement seen in both treatment groups. Radiographic results show that the Prestige II disc maintains motion at the treated level without adjacent-segment compromise. Conclusions Cervical spine arthroplasty is an exciting and rapidly developing surgical treatment option. An objective comparison with fusion is important to advance this option. This is the first prospective randomized trial in which cervical arthroplasty is compared with fusion. The preliminary results from this limited number of patients indicate that the Prestige II disc is potentially a viable alternative to fusion for primary cervical disc disease; however, further clinical studies with larger sample sizes will be required to show statistical equivalence.

scholarly journals Structured postoperative physiotherapy in patients with cervical radiculopathy: 6-month outcomes of a randomized clinical trial

2018 ◽  
Vol 28 (1) ◽  
pp. 1-9 ◽  
Author(s):  
Johanna Wibault ◽  
Birgitta Öberg ◽  
Åsa Dedering ◽  
Håkan Löfgren ◽  
Peter Zsigmond ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Clinical Guidelines ◽  
Cervical Radiculopathy ◽  
Behavioral Approach ◽  
Cervical Disc ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Arm Pain ◽  
Neck Disability

OBJECTIVEStructured physiotherapy has been suggested as treatment before as well as after surgery to improve clinical outcomes in patients with cervical radiculopathy (CR), but randomized clinical trials to inform evidence-based clinical guidelines for the treatment of patients with CR after surgery are lacking. The aim of this study was to compare the results of structured postoperative physiotherapy combining neck-specific exercises with a behavioral approach to a standard postoperative approach in patients who had undergone surgery for cervical disc disease with CR at 6 months after surgery.METHODSPatients with cervical disc disease and persistent CR who were scheduled for surgery were randomized preoperatively to structured postoperative physiotherapy (n = 101) or a standard postoperative approach (n = 100). The latter included pragmatic physiotherapy in accordance with the usual Swedish postoperative care. Outcome measures included patient-reported neck disability as measured with the Neck Disability Index (NDI), intensity and frequency of neck and arm pain, global outcome of treatment, and expectation fulfillment, as well as enablement.RESULTSPatients who received structured postoperative physiotherapy reported greater expectation fulfillment (p = 0.01), and those who attended at least 50% of the treatment sessions reported less neck pain frequency (p = 0.05), greater expectation fulfillment (p = 0.001), and greater enablement (p = 0.04) compared with patients who received the standard postoperative approach. No other difference between treatment groups was found (p > 0.15). The NDI and neck and arm pain intensity were improved in both groups at 6 months after surgery (p < 0.001). Additional use of postoperative physiotherapy was reported by 61% of the patients who received the standard postoperative approach.CONCLUSIONSThe results from this first randomized clinical trial of postoperative physiotherapy showed only minor additional benefit of structured postoperative physiotherapy compared with standard postoperative approach 6 months postoperatively in patients who underwent surgery for cervical disc disease with CR. Patients who received structured postoperative physiotherapy reported higher expectation fulfillment, and many patients in the standard postoperative approach group perceived a need for additional treatments after surgery, suggesting that patients with CR are in need of further postoperative support. The results confirm that neck-specific exercises are tolerated postoperatively by patients with CR, but more studies of postoperative physiotherapy are needed to inform clinical guidelines for this patient group.Clinical trial registration no.: NCT01547611 (clinicaltrials.gov)

Sign in / Sign up

Export Citation Format

Share Document