Prospective Study on Ennovate® Pedicle Screw Fixation in Isthmic Spondylolisthesis Patients

NCT ID: NCT03507881

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2019-01-18

Brief Summary

The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation of the performed reposition to come to satisfactory clinical results.

Detailed Description

Adult Isthmic spondylolisthesis, which is associated with "spondylolysis," is defined as an osseous discontinuity of the vertebral arch at the isthmus (the pars interarticularis), which usually occurs in the fifth lumbar vertebra. The prevalence of isthmic spondylosis is proposed to be about 6% to 26% in different studies. The European Spine Tango registry found 15%. It is proposed to affect more men than women. Conservative treatments including braces, physical therapy, and medication are shown to be effective for some patients; however, surgical treatments are mainly the final effective treatment. There are several different options for surgery among which posterolateral fusion (PLF) is considered as the method of choice. It is shown that PLF is more effective than conservative treatments such as exercise. The fusion helps to fix the motion of the affected segment and therefore, might lead to pain reduction. Decompression, supplemental instrumentation, and supplemental anterior column support are also considered for treatment. These treatment strategies can be used separately or in any combination; however, studies trying to compare separate treatments with a combination of them have led to inconsistent results.

Supplementary pedicle screws might be added to fusion methods for fixation and it is proposed that they have the ability to correct the deformity, reduce the listhesis, and increase the fusion rates, although a majority of the studies comparing instrumented PLF and noninstrumented PLF could not show the superiority of instrumented approaches. The literature has been reviewed in 2000 already, and the method has already been proved to be "practical, safe, and effective" for various spinal indications. Other authors found a better result for isthmic spondylolisthesis patients with posterior lumbar interbody Fusion (PLIF), vs. PLF, especially for high grade isthmic spondylolisthesis.

The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation also in the long-term.

Conditions

Spine Fusion; Isthmic Spondylolisthesis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ennovate

Implantation of an Ennovate® internal fixation

fusion

Intervention Type: DEVICE

Internal fixation

Interventions

fusion

Internal fixation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Symptomatic single-level IS (L4-S1), (VAS > 30mm, treated conservatively for a minimum of 6 months)
• Isthmic Spondylolisthesis Meyerding grade I and II
• Signed Informed Consent of the patient regarding the participation in this study

Exclusion Criteria

• Multilevel IS
• Severe degenerative changes of cranial adjacent level (disc height of <50% of the next healthy segment,
• Previous lumbar spine surgery except microdiscectomy or micro- decompression of the index level
• Patients psychically or mentally not able to give or refuse consent
• Patients psychically or mentally not able to answer the questions regarding their health status and quality of life
• Pregnancy (current or planned)
• BMI >35
• Systemic or local infection
• Chemotherapy or radiation ongoing
• Desire of early retirement (running pension request)
• All contraindications as listed in the instructions for use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Raylytic GmbH

INDUSTRY

Sponsor Role: collaborator

ZKS Münster

UNKNOWN

Sponsor Role: collaborator

Aesculap AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klinikum der J. W. Goethe-Universität, Klinik für Allgemein- und Visceralchirurgie

Frankfurt am Main, , Germany

Katholisches Klinikum Koblenz

Koblenz, , Germany

Sana Klinikum Offenbach GmbH

Offenbach, , Germany

Countries

Germany

References

Gaines RW Jr. The use of pedicle-screw internal fixation for the operative treatment of spinal disorders. J Bone Joint Surg Am. 2000 Oct;82(10):1458-76. doi: 10.2106/00004623-200010000-00013.

Reference Type: BACKGROUND

PMID: 11057475 (View on PubMed)

Dehoux E, Fourati E, Madi K, Reddy B, Segal P. Posterolateral versus interbody fusion in isthmic spondylolisthesis: functional results in 52 cases with a minimum follow-up of 6 years. Acta Orthop Belg. 2004 Dec;70(6):578-82.

Reference Type: BACKGROUND

PMID: 15669459 (View on PubMed)

Etemadifar MR, Hadi A, Masouleh MF. Posterolateral instrumented fusion with and without transforaminal lumbar interbody fusion for the treatment of adult isthmic spondylolisthesis: A randomized clinical trial with 2-year follow-up. J Craniovertebr Junction Spine. 2016 Jan-Mar;7(1):43-9. doi: 10.4103/0974-8237.176623.

Reference Type: BACKGROUND

PMID: 27041885 (View on PubMed)

Taillard WF. Etiology of spondylolisthesis. Clin Orthop Relat Res. 1976 Jun;(117):30-9.

Reference Type: BACKGROUND

PMID: 1277680 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19139672 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 8242953 (View on PubMed)

Jacobs WC, Vreeling A, De Kleuver M. Fusion for low-grade adult isthmic spondylolisthesis: a systematic review of the literature. Eur Spine J. 2006 Apr;15(4):391-402. doi: 10.1007/s00586-005-1021-4. Epub 2005 Oct 11.

Reference Type: BACKGROUND

PMID: 16217665 (View on PubMed)

GILL GG, MANNING JG, WHITE HL. Surgical treatment of spondylolisthesis without spine fusion; excision of the loose lamina with decompression of the nerve roots. J Bone Joint Surg Am. 1955 Jun;37-A(3):493-520. No abstract available.

Reference Type: BACKGROUND

PMID: 14381447 (View on PubMed)

France JC, Yaszemski MJ, Lauerman WC, Cain JE, Glover JM, Lawson KJ, Coe JD, Topper SM. A randomized prospective study of posterolateral lumbar fusion. Outcomes with and without pedicle screw instrumentation. Spine (Phila Pa 1976). 1999 Mar 15;24(6):553-60. doi: 10.1097/00007632-199903150-00010.

Reference Type: BACKGROUND

PMID: 10101819 (View on PubMed)

Moller H, Hedlund R. Instrumented and noninstrumented posterolateral fusion in adult spondylolisthesis--a prospective randomized study: part 2. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1716-21. doi: 10.1097/00007632-200007010-00017.

Reference Type: BACKGROUND

PMID: 10870149 (View on PubMed)

Thomsen K, Christensen FB, Eiskjaer SP, Hansen ES, Fruensgaard S, Bunger CE. 1997 Volvo Award winner in clinical studies. The effect of pedicle screw instrumentation on functional outcome and fusion rates in posterolateral lumbar spinal fusion: a prospective, randomized clinical study. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2813-22. doi: 10.1097/00007632-199712150-00004.

Reference Type: BACKGROUND

PMID: 9431617 (View on PubMed)

McGuire RA, Amundson GM. The use of primary internal fixation in spondylolisthesis. Spine (Phila Pa 1976). 1993 Sep 15;18(12):1662-72. doi: 10.1097/00007632-199309000-00015.

Reference Type: BACKGROUND

PMID: 8235847 (View on PubMed)

Other Identifiers

AAG-O-H-1619

Identifier Type: -

Identifier Source: org_study_id