ArcadiusXP L Post Market Clinical Follow-Up

Degenerative Disc Disease Clinical Trial

— ArcadiusXPLPMS  

Official title:

Clinical Follow-up of the ArcadiusXP L Stand Alone Intervertebral Body Fusion Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895426
• Other study ID #: AAG-O-H-1227
• Status: Completed
• Phase: N/A
• First received: July 5, 2013
• Last updated: March 21, 2017
• Start date: April 2013
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect clinical and radiological mid-term (2 years) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 32 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• all indications as given by the instructions for use

• Patients with persisting lumbosacral and pseudo-radicular pain scheduled for monosegmental lumbar interbody fusion from L4 to S1

• Age 18 - 60

• at least 6 months of unsuccessful treatment including conservative measures

• Non-sequestrated and subligamentous prolapse

Exclusion Criteria:

• all contraindications, which are listed in the instructions for use.

• existing pregnancy, planned or occurring during study period

• patients with a higher degree of segmental degeneration in other than the segment to be operated

• body- mass-index (BMI) > 30

• Systemic or local infection

• Increased risk of osteoporosis according to assessment by the SCORE evaluation

• Bone metabolism disorders

• Chemotherapy or radiotherapy (ongoing or planned)

• Participation in another clinical trial

• Scheduled for spinal litigation

• Other serious conditions that hinder the participation in the study

• Nanogel® filling of the cage, prior to implantation was not done

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Locations

Country	Name	City	State
Germany	Sana Kliniken Sommerfeld	Kremmen
Germany	St. Bonifatius Hospital Lingen	Lingen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ODI (2y) - ODI(preop)	Difference between Oswestry Disability Index (ODI) at 2 years and preoperative ODI	2 years
Secondary	Fusion/arthrodesis status, and further radiological documentation of operated and adjacent levels	Angle difference in flexion and extension radiographs at each timepoint; analysis of AP and ML x-rays regarding changes in bone density (identification of bone bridges): CT/MRT are considered when available; consideration of pot. radiolucencies around the	2 years
Secondary	Overall success	ODI at each timepoint	2 years
Secondary	Overall success	Improvement of at least 15 points in the Oswestry Disability Index score compared to the baseline score; No device failures requiring revision, reoperation, or removal; Absence of major complications, defined as major vessel injury or major neurological deterioration (e.g., nerve root injury); Maintenance or improvement in neurological status vs. baseline, with no permanent neurological deficits compared to baseline status.	2 years
Secondary	Pain (back and leg)	Pain levels (back and leg) as measured via Visual Analogue scale (VAS) at each timepoint	2 years
Secondary	Adverse events		2 years
Secondary	Patient satisfaction	"Would you have the Operation again?"	2 years
Secondary	Concomitant pain medication	Documentation of drug related medication	2 years