Medium-Term Follow-Up of Alpha-D Cervical Disk Prosthesis

NCT05262478 | Completed

• 1 other identifier: ATANEUROSURGERY-2
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Prostheses use subsequently became prevalent and a number of studies were conducted. However, prosthesis-associated heterotropic ossification (HO) in the segments with prostheses was reported in 2005, which disrupted mobility and caused fusion. In the present study, we aimed to investigate the clinical outcomes, HO incidence, and prosthesis mobility in the patients following the operative use of Alpha-D disc prosthesis as developed and used by the authors to treat cervical disk diseases.

Conditions

Cervical Disc Disease

Outcome Measures

Primary Outcomes (1)

• Heterotropic ossification

  McAfee-Mehren classification

  Postoperative 18-78.months

Secondary Outcomes (2)

• visual analog scale

  4 and 12 months after surgery

• neck disability index

  4 and 12 months after surgery

Study Arms (1)

Alpha-D cervical disc prosthesis

Alpha-D cervical disc prosthesis was developed jointly by the Spine Center of Koç University Faculty of Medicine and Toledo University Bioengineering Department. It was designed as a single unit to ensure user-friendly administration for surgeons, and it was designed and manufactured to reproduce the movements of the normal cervical movement segment.

Device: Alpha-D CDP

Interventions

Alpha-D CDP DEVICE

Alpha-D cervical disc prosthesis was developed jointly by the Spine Center of Koç University Faculty of Medicine and Toledo University Bioengineering Department. It was designed as a single unit to ensure user-friendly administration for surgeons, and it was designed and manufactured to reproduce the movements of the normal cervical movement segment.

Alpha-D cervical disc prosthesis

Eligibility Criteria

• Age: 27 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We included 33 patients with cervical disc hernia and associated radiculopathy upon radiological examination, who underwent a cervical discectomy and received cervical disc protheses (CDP; arthroplasty) with a single-level anterior discectomy.

You may qualify if:

• cervical disc hernia
• underwent cervical discectomy and received cervical disc prostheses

You may not qualify if:

• history of cervical surgery,
• kyphotic deformity,
• rheumatological or other systemic diseases,
• severe osteophytes caused by advanced degenerative disc disease
• severe spinal stenosis

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, Turkey (Türkiye)

Location

Related Publications (2)

• Leven D, Meaike J, Radcliff K, Qureshi S. Cervical disc replacement surgery: indications, technique, and technical pearls. Curr Rev Musculoskelet Med. 2017 Jun;10(2):160-169. doi: 10.1007/s12178-017-9398-3.

  PMID: 28493215 BACKGROUND

• Park JH, Rhim SC, Roh SW. Mid-term follow-up of clinical and radiologic outcomes in cervical total disk replacement (Mobi-C): incidence of heterotopic ossification and risk factors. J Spinal Disord Tech. 2013 May;26(3):141-5. doi: 10.1097/BSD.0b013e31823ba071.

  PMID: 22105106 BACKGROUND

Study Officials

• Mehmet K Karadag

  Mehmet Kursat Karadag

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: January 1, 2022
• Primary Completion: February 1, 2022
• Study Completion: February 15, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

TU (1)