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Spinal Canal StenosisNCT05182489

Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

A study testing Medtronic Adaptix™ titanium implants and Medtronic CAPSTONE® PEEK cage in people with Spinal Canal Stenosis and Spondylolisthesis, run by Ohio State University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle screw instrumentation, using one of the following interbody cages; the Medtronic Adaptix™ cage… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Medtronic Adaptix™ titanium implants and Medtronic CAPSTONE® PEEK cage
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
19 Nov 2021to 1 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the Medtronic Adaptix™ titanium cage or Medtronic CAPSTONE® PEEK cage in conjunction with a 50:50 mixture of local autograft and GRAFTON™ DBM DBF, and supplementation with a pedicle screw system.
  • Subject must be over the age of 18 years old.
  • Subject has been unresponsive to conservative care for a minimum of 6 months.
  • The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.

Who cannot join

  • Subjects with previous lumbar arthrodesis surgery.
  • Subjects requiring additional bone grafting materials other than local autograft bone or GRAFTON™ DBM DBF.
  • Subject has inadequate tissue coverage over the operative site.
  • Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
  • Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
  • Subject has an active local or systemic infection.
Show all 15Show fewer
  • Subject has a metal sensitivity/foreign body sensitivity.
  • Subject is allergic to antibiotics (gentamicin) or processing solutions found in GRAFTON™.
  • Subject is morbidly obese, defined as a body mass index (BMI) greater than 45.
  • Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
  • Subject is currently involved in another investigational drug or device study that could confound study data.
  • Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
  • Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating.
  • Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
  • Subject is a prisoner.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Ohio State University Wexner Medical Center Neurological Surgery

    Columbus, Ohio, 43219

Other trials in United States

About this study

Official title: Lumbar Fusion With Micro and Nano-textured Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Adaptix™ Versus PEEK Cages

The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle screw instrumentation, using one of the following interbody cages; the Medtronic Adaptix™ cage with roughened micro and nano-textured titanium surfaces or the CAPSTONE® poly-ether-ether-ketone cage.

Read the detailed description

The randomized controlled trial will prospectively evaluate the efficacy of Medtronic Adaptix™ titanium implants supplemented with a pedicle screw system as compared to a Medtronic CAPSTONE® PEEK cage currently used in routine fashion for lumbar interbody fusion procedures. This study will capture clinical and radiographic outcomes on patients up to 2 years postoperatively. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).

This single-centered study will enroll up to 100 subjects, with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for combined interbody/posterolateral lumbar fusion surgery. The inclusion/exclusion criteria are listed below.

Being tested
Medtronic Adaptix™ titanium implants, Medtronic CAPSTONE® PEEK cage
Medical subject headings
Spinal Stenosis, Spondylolisthesis, Osteophyte, Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic Adaptix™ titanium implantsDevice

    Patients who will be having a spinal fusion procedure as part of their standard of care treatment will be randomized to receive either the Medtronic titanium or the PEEK cage supplemented with a pedicle screw system and milled local autograft bone supplemented with GRAFTON DBM DBF. In order to assess fusion, patients will undergo a research-only CT Scan at 6 months post-surgery.

  • Medtronic CAPSTONE® PEEK cageDevice

    Medtronic CAPSTONE® PEEK cage

Study groups in NCT05182489
Study groupRoleWhat they receive
Medtronic Adaptix™ titanium implantsExperimentalThis arm will use Medtronic Adaptix™ titanium implants supplemented with a pedicle screw system. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).
Receives: Device: Medtronic Adaptix™ titanium implants
Medtronic CAPSTONE® PEEK cageActive comparatorThis arm will use Medtronic CAPSTONE® PEEK cage supplemented with a pedicle screw system. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).
Receives: Device: Medtronic CAPSTONE® PEEK cage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fusion rate at 6 months

    A subject will be considered a success if fusion is a Grade BSF-3 at 6 months. The primary outcome measure of effectiveness will be determined by the fusion rate at 6 months post-operatively in subjects implanted with either titanium cage as compared to the PEEK cage.

    Measured: 6 months

Secondary outcomes (1)
  1. Timing of fusion

    Secondary measures of effectiveness will be determined by the principal investigator by evidence and timing of fusion observed in X-rays post-operatively (3, 6, 12, and 24 months).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start19 Nov 2021
  3. Primary completion1 Oct 2025
  4. Study completion1 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
All subjects will be randomized in the trial to receive either the Medtronic titanium or the PEEK cage supplemented with a pedicle screw system and milled local autograft bone supplemented with GRAFTON™ DBM DBF. Subject randomization will be stratified according to smoking status. Subjects will be blinded to their group status for the duration of the study assessments and procedures (24 months post-operatively).
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182489
Sponsor's protocol ID
2021H0244
Status last verified
Jun 2025
First submitted
9 Dec 2021
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Anjarwalla NK, Brown LC, McGregor AH. The outcome of spinal decompression surgery 5 years on. Eur Spine J. 2007 Nov;16(11):1842-7. doi: 10.1007/s00586-007-0393-z. Epub 2007 May 23.

    PubMed 17520297
  • Banik BL, Riley TR, Platt CJ, Brown JL. Human Mesenchymal Stem Cell Morphology and Migration on Microtextured Titanium. Front Bioeng Biotechnol. 2016 May 10;4:41. doi: 10.3389/fbioe.2016.00041. eCollection 2016.

    PubMed 27243001
  • Fernyhough JC, Schimandle JJ, Weigel MC, Edwards CC, Levine AM. Chronic donor site pain complicating bone graft harvesting from the posterior iliac crest for spinal fusion. Spine (Phila Pa 1976). 1992 Dec;17(12):1474-80. doi: 10.1097/00007632-199212000-00006.

    PubMed 1471005
  • Gittens RA, Olivares-Navarrete R, McLachlan T, Cai Y, Hyzy SL, Schneider JM, Schwartz Z, Sandhage KH, Boyan BD. Differential responses of osteoblast lineage cells to nanotopographically-modified, microroughened titanium-aluminum-vanadium alloy surfaces. Biomaterials. 2012 Dec;33(35):8986-94. doi: 10.1016/j.biomaterials.2012.08.059. Epub 2012 Sep 16.

    PubMed 22989383
  • Hangai M, Kaneoka K, Kuno S, Hinotsu S, Sakane M, Mamizuka N, Sakai S, Ochiai N. Factors associated with lumbar intervertebral disc degeneration in the elderly. Spine J. 2008 Sep-Oct;8(5):732-40. doi: 10.1016/j.spinee.2007.07.392. Epub 2007 Nov 26.

    PubMed 18037353
  • Kurtz SM, Devine JN. PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomaterials. 2007 Nov;28(32):4845-69. doi: 10.1016/j.biomaterials.2007.07.013. Epub 2007 Aug 7.

    PubMed 17686513
  • Laurencin C, Khan Y, El-Amin SF. Bone graft substitutes. Expert Rev Med Devices. 2006 Jan;3(1):49-57. doi: 10.1586/17434440.3.1.49.

    PubMed 16359252
  • Laurie SW, Kaban LB, Mulliken JB, Murray JE. Donor-site morbidity after harvesting rib and iliac bone. Plast Reconstr Surg. 1984 Jun;73(6):933-8. doi: 10.1097/00006534-198406000-00014.

    PubMed 6374708
  • Lee CS, Hwang CJ, Lee DH, Kim YT, Lee HS. Fusion rates of instrumented lumbar spinal arthrodesis according to surgical approach: a systematic review of randomized trials. Clin Orthop Surg. 2011 Mar;3(1):39-47. doi: 10.4055/cios.2011.3.1.39. Epub 2011 Feb 15.

    PubMed 21369477
  • Long EG, Buluk M, Gallagher MB, Schneider JM, Brown JL. Human mesenchymal stem cell morphology, migration, and differentiation on micro and nano-textured titanium. Bioact Mater. 2019 Sep 19;4:249-255. doi: 10.1016/j.bioactmat.2019.08.001. eCollection 2019 Dec.

    PubMed 31667441
  • Nemoto O, Asazuma T, Yato Y, Imabayashi H, Yasuoka H, Fujikawa A. Comparison of fusion rates following transforaminal lumbar interbody fusion using polyetheretherketone cages or titanium cages with transpedicular instrumentation. Eur Spine J. 2014 Oct;23(10):2150-5. doi: 10.1007/s00586-014-3466-9. Epub 2014 Jul 12.

    PubMed 25015180
  • Olivares-Navarrete R, Hyzy SL, Hutton DL, Erdman CP, Wieland M, Boyan BD, Schwartz Z. Direct and indirect effects of microstructured titanium substrates on the induction of mesenchymal stem cell differentiation towards the osteoblast lineage. Biomaterials. 2010 Apr;31(10):2728-35. doi: 10.1016/j.biomaterials.2009.12.029. Epub 2010 Jan 6.

    PubMed 20053436
  • Olivares-Navarrete R, Hyzy SL, Gittens RA 1st, Schneider JM, Haithcock DA, Ullrich PF, Slosar PJ, Schwartz Z, Boyan BD. Rough titanium alloys regulate osteoblast production of angiogenic factors. Spine J. 2013 Nov;13(11):1563-70. doi: 10.1016/j.spinee.2013.03.047. Epub 2013 May 14.

    PubMed 23684238
  • Quint U, Wilke HJ. Grading of degenerative disk disease and functional impairment: imaging versus patho-anatomical findings. Eur Spine J. 2008 Dec;17(12):1705-13. doi: 10.1007/s00586-008-0787-6. Epub 2008 Oct 7.

    PubMed 18839226
  • Santos ER, Goss DG, Morcom RK, Fraser RD. Radiologic assessment of interbody fusion using carbon fiber cages. Spine (Phila Pa 1976). 2003 May 15;28(10):997-1001. doi: 10.1097/01.BRS.0000061988.93175.74.

    PubMed 12768137

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Adaptix™ titanium implants and Medtronic CAPSTONE® PEEK cage in people with Spinal Canal Stenosis and Spondylolisthesis, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fusion rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05182489, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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