NCT00939406

Brief Summary

The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. The device is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2009

Typical duration for phase_2

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

3 years

First QC Date

July 14, 2009

Last Update Submit

December 19, 2012

Conditions

Degenerative Spinal StenosisDisk Herniation

Outcome Measures

Primary Outcomes (2)

  • Rate of adverse events

    6 months

  • Extent of epidural fibrosis

    12 months

Secondary Outcomes (1)

  • differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results

    12 months

Study Arms (2)

Control

NO INTERVENTION

Control group consists of subjects randomized to the control arm who will receive lumbar decompression surgery (laminotomy or laminectomy) alone

Hyalospine

EXPERIMENTAL

Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.

Device: Hyalospine

Interventions

HyalospineDEVICE

Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.

Hyalospine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for elective single- or two-level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis and/or disk herniation.
  • Subjects who have failed conservative care for at least 6 weeks.

You may not qualify if:

  • Contraindication to MRI
  • Instrumented fusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main

Frankfurt, 60389, Germany

Location

Sint Maartenskliniek, Nijmegen, The Netherlands

Woerden, Netherlands

Location

Klinik Sonnehof

Bern, Canton of Bern, 3006, Switzerland

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Pavlov, MD

    Sint Maartenskliniek, Nijmegen, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

NL(1)CH(1)DE(1)