Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01406405
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2011-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050939', 'term': 'Gene Fusion'}], 'ancestors': [{'id': 'D011995', 'term': 'Recombination, Genetic'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2011-07-27', 'studyFirstSubmitQcDate': '2011-07-29', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Scores', 'timeFrame': '24 (+/- 2) months', 'description': 'Improvement in the Neck/Arm or Low Back/Leg Visual Analog pain Scale (VAS) scores. A 30% reduction in pain intensity will be considered to be a successful response to treatment.'}], 'secondaryOutcomes': [{'measure': 'Clinical and Radiographic Outcomes', 'timeFrame': '3 (+/-2) weeks and 24 (+/- 2) months', 'description': '* Assessment of Neck or Lower Back Disability Scores\n* Assessment of SF-36 Health Survey\n* Assessment of restoration of vertebral height, sagittal alignment, and graft subsidence\n* Assessment of fusion rates'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Degenerative disc disease', 'spinal stenosis', 'herniated disc'], 'conditions': ['Degenerative Disc Disease']}, 'referencesModule': {'references': [{'pmid': '27689425', 'type': 'DERIVED', 'citation': 'Villavicencio AT, Nelson EL, Kantha V, Burneikiene S. Prediction based on preoperative opioid use of clinical outcomes after transforaminal lumbar interbody fusions. J Neurosurg Spine. 2017 Feb;26(2):144-149. doi: 10.3171/2016.7.SPINE16284. Epub 2016 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'Purpose The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.', 'detailedDescription': 'Following surgery study subjects will be evaluated at the following intervals: 3 (+/- 2 weeks), 6 (+/- 1 month), 12 (+/- 2 months), 24 (+/- 2 months) months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Boulder Neurosurgical Associates patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Lumbar Fusion Patient Group\n\nInclusion Criteria:\n\n* Skeletally mature adults between 18 and 70 years old\n* Patients with back and leg pain due to degenerative disc disease, scheduled for TLIF/PLIF approach utilizing an interbody spacer and supplemental posterior fixation at 1, 2 or 3 adjacent levels\n* Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention\n* Willing and able to comply with the requirements of the protocol including followup requirements\n* Willing and able to sign a study specific informed consent.\n\nExclusion Criteria:\n\n* More than 3 intervertebral levels to be fused\n* Posterior fixation used at more than 1 level for 1-level intervertebral fusion\n* Posterior fixation used at more than 2 levels for 2-level intervertebral fusion\n* Posterior fixation used at more than 3 levels for 3-level intervertebral fusion\n* Any additional approaches, e.g. anterior, XLIF\n* Active local or systemic infection\n* Prior interbody fusion surgery at the index level\n* Prior fusion at the adjacent levels\n* Previous known allergy to polyetheretherketone (PEEK) or titanium alloy\n\nCervical Fusion Patient Group\n\nInclusion Criteria:\n\n* Skeletally mature adults between 18 and 70 years old\n* Patients with neck and/or arm pain due to degenerative disc disease, scheduled for ACDF approach utilizing an interbody spacer and anterior cervical plate at 1, 2 or 3 adjacent levels\n* Completed at least 6 weeks of conservative therapy or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention\n* Willing and able to comply with the requirements of the protocol including followup requirements\n* Willing and able to sign a study specific informed consent\n\nExclusion Criteria:\n\n* More than 3 vertebral levels to be fused\n* Any additional approaches, e.g. posterior cervical fusion\n* Active local or systemic infection\n* Prior interbody fusion surgery at the index level\n* Prior fusion at the adjacent level\n* Previous known allergy to polyetheretherketone (PEEK) or titanium alloy'}, 'identificationModule': {'nctId': 'NCT01406405', 'acronym': 'PEEK', 'briefTitle': 'PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Justin Parker Neurological Institute'}, 'officialTitle': 'Prospective Randomized Clinical Trial Comparing PEEK and Allograft Spacers in Patients Undergoing Spinal Intervertebral Fusion Surgeries', 'orgStudyIdInfo': {'id': 'JPNI2001-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PEEK cages', 'description': 'Patients will have fusion surgery performed using polyetheretherketone (PEEK) cages', 'interventionNames': ['Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)']}, {'label': 'Allograft spacers', 'description': 'Patients will have fusion surgery performed using allograft spacers', 'interventionNames': ['Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)']}], 'interventions': [{'name': 'Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)', 'type': 'PROCEDURE', 'description': 'Lumbar or cervical fusion', 'armGroupLabels': ['Allograft spacers', 'PEEK cages']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Neurosurgical Associates', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}], 'overallOfficials': [{'name': 'Alan T Villavicencio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boulder Neurosurgical Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Justin Parker Neurological Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}