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

NCT03507881 | Terminated

• 1 other identifier: AAG-O-H-1619
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 3

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.

Conditions

Spine Fusion; Isthmic Spondylolisthesis

Keywords

isthmic spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• Leg pain

  Leg Pain measured by Visual analogue scale (VAS) after 1 year follow-up: measured by Visual Analogue Scale: The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

  1 year

Secondary Outcomes (10)

• Leg Pain

  Preoperative, 3 months, 6 months

• Back Pain

  Preoperative, 3 months, 6 months, 1 year

• Functional Disability

  Preoperative, 3 months, 6 months, 1 year

• Patient satisfaction

  3 months, 6 months, 1 year

• Quality of Life

  preoperative, 3 months, 6 months, 1 year

Study Arms (1)

Ennovate

Implantation of an Ennovate® internal fixation

Device: fusion

Interventions

fusion DEVICE

Internal fixation

Ennovate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead
• Raylytic GmbH: collaborator
• ZKS Münster: collaborator

Study Sites (3)

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

Frankfurt am Main, 60590, Germany

Location

Katholisches Klinikum Koblenz

Koblenz, 56073, Germany

Location

Sana Klinikum Offenbach GmbH

Offenbach, 63069, Germany

Location

Related Publications (14)

• 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.

  PMID: 11057475 BACKGROUND

• 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.

  PMID: 15669459 BACKGROUND

• 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.

  PMID: 27041885 BACKGROUND

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

  PMID: 1277680 BACKGROUND

• Kalichman L, Kim DH, Li L, Guermazi A, Berkin V, Hunter DJ. Spondylolysis and spondylolisthesis: prevalence and association with low back pain in the adult community-based population. Spine (Phila Pa 1976). 2009 Jan 15;34(2):199-205. doi: 10.1097/BRS.0b013e31818edcfd.

  PMID: 19139672 BACKGROUND

• McTimoney CA, Micheli LJ. Current evaluation and management of spondylolysis and spondylolisthesis. Curr Sports Med Rep. 2003 Feb;2(1):41-6. doi: 10.1249/00149619-200302000-00008.

  PMID: 12831675 BACKGROUND

• STEWART TD. [The age incidence of neural-arch defects in Alaskan natives, considered from the standpoint of etiology]. J Bone Joint Surg Am. 1953 Oct;35-A(4):937-50. No abstract available. Undetermined Language.

  PMID: 13108895 BACKGROUND

• Osterman K, Schlenzka D, Poussa M, Seitsalo S, Virta L. Isthmic spondylolisthesis in symptomatic and asymptomatic subjects, epidemiology, and natural history with special reference to disk abnormality and mode of treatment. Clin Orthop Relat Res. 1993 Dec;(297):65-70.

  PMID: 8242953 BACKGROUND

• 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.

  PMID: 16217665 BACKGROUND

• 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.

  PMID: 14381447 BACKGROUND

• 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.

  PMID: 10101819 BACKGROUND

• 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.

  PMID: 10870149 BACKGROUND

• 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.

  PMID: 9431617 BACKGROUND

• 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.

  PMID: 8235847 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: July 31, 2018
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

DE (3)