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This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elastic spine pad | Experimental | Patients, who receive Elastic Spine Pad (TM) as cervical disc prosthesis after ventral discectomy. |
|
| Rotaio | Active Comparator | Patients, who receive Rotaio (TM) as cervical disc prosthesis after ventral discectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior cervical discectomy with prosthetic disc replacement / ESP. | Device | Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neck disability index compared to baseline | 6 weeks, 3, 6, 12 and 24 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline | 6 weeks, 3, 6, 12 and 24 months postoperative | |
| Change in EuroQOL (EQ-5D) compared to baseline | 6 weeks, 3, 6, 12 and 24 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinikum Dresden | Recruiting | Dresden | 01307 | Germany |
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| Anterior cervical discectomy with prosthetic disc replacement / Rotaio. | Device | Anterior cervical discectomy, with the use of the Rotaio prosthesis (Manufacturer: Signus Med, Alzenau, Germany) for the disc replacement. |
|
| Change in Core Outcome Measure Index (COMI) compared to baseline | 6 weeks, 3, 6, 12 and 24 months postoperative |
| Change in flexion and extension radiographs compared to baseline | 6 weeks, 3, 6 and 12 months postoperative |
| Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline | 6 weeks, 3, 6 and 12 months postoperative |
| Change in consumption of analgetics compared to baseline | The change in analgetics consumption will be assessed on a scale of increase - stable - reduction. | 6 weeks, 3, 6, 12 and 24 months postoperative |
| Return to work | 6 weeks postoperative |
| Return to work | 3 months postoperative |
| Return to work | 6 months postoperative |
| Return to work | 12 months postoperative |
| Return to work | 24 months postoperative |
| Mortality | 6 weeks postoperative |
| Mortality | 3 months postoperative |
| Mortality | 6 months postoperative |
| Mortality | 12 months postoperative |
| Mortality | 24 months postoperative |
| Adverse effects | 6 weeks postoperative |
| Adverse effects | 3 months postoperative |
| Adverse effects | 6 months postoperative |
| Adverse effects | 12 months postoperative |
| Adverse effects | 24 months postoperative |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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