An interventional study of Structural allograft and Tritanium C in Degenerative Disc Disease, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Not applicable, Interventional, and Basic science
Among 232 studies in Intervertebral Disc Degeneration with a site in United States — 41 open to participants now, 60 under way, 5 of them phase 3. Intervertebral Disc Degeneration · United States.
Among the 232 studies in Intervertebral Disc Degeneration with a site in United States, this one is the 64th largest by planned enrollment of the 141 interventional ones that give a count, is one of 17 that started in 2020, is one of 90 with no phase, reaches primary completion later than 25 of the 59 other live ones, and was the 156th registered.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
Browse Intervertebral Disc Degeneration studies →41 of the 232 studies in Intervertebral Disc Degeneration with a site in United States are open now. Recruiting first, the newest first:
Weill Medical College of Cornell University · Sites in United States
CGBio Inc. · Sites in United States
EicOsis Human Health Inc. · Sites in United States
DiscGenics, Inc. · Sites in United States
VIVEX Biologics, Inc. · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 60 Intervertebral Disc Degeneration studies recruiting now, 29 (48%) set no upper age limit and 16 (27%) stop at 75 or younger; 7 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
232 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 20 · Phase 3 18 · Phase 4 8
First in 1998; this study’s year is marked. 17 started in 2020.
This study's planned enrollment of 60 is close to the median of 60 across 256 interventional studies indexed under Intervertebral Disc Degeneration.
Median enrollment 57 across the 141 interventional studies, 118 across the 91 observational. Of the 130 that completed or were terminated, 44 (34%) have results posted.
This tab as a report to print or save as PDF → With an account.
165 of 232 have an industry lead sponsor. The 10 most frequent:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) is the lead sponsor of 49 studies on the registry; 20 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) has 1 study filed under Intervertebral Disc Degeneration — fewer than ten, so there is no comparison to draw.
17 of the studies in Intervertebral Disc Degeneration with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06325566Phase 3Mesoblast, Ltd.Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain | 2027-07 |
| NCT07254806Phase 3DiscGenics, Inc.A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease | 2027-11-24 |
| NCT05740176Synergy Spine SolutionsThe Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery | 2026-11 |
| NCT05037968Kuros Biosurgery AGMagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion | 2026-12 |
| NCT04388332Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)ACDF Using Structural Allograft vs. Tritanium C | 2026-12 |
Among the 232 studies in Intervertebral Disc Degeneration with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is an observational, descriptive, prospective and retrospective data collection study. The purpose of this study is to observe radiographic outcomes of patients who will undergo anterior cervical discectomy and fusion (ACDF) utilizing Tritanium C (Stryker Spine). The rate of fusion success and adverse events will be compared retrospectively to patients who underwent instrumented ACDF utilizing structural allograft bone with plates.
Retrospective Cohort: A maximum of 200 patients that received one or two level ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips at AHN in the past will retrospectively be screened for inclusion into a pool of potential candidates for the retrospective cohort. Patients will be included in this preliminary pool if the following information are available: age (at surgery), sex, body mass index (at surgery), no smoking at baseline, number of levels operated on, which specific levels were operated on, standard of care clinic follow-up at 6 and 12 months (3 month visit not required) and imaging that can be used to assess fusion at baseline, 6 and 12 months (3 month imaging not required). If available, NDI and VAS, questionnaires completed during baseline and post-op visits will be collected.
This pool of retrospective cohort candidates will be used to match the patients in the prospective cohort to patients treated with structural allograft using a 1:2 ratio. Thus, 40 patients will ultimately be included in the retrospective cohort.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients may not be enrolled in the study if any of the following exclusion criteria are present:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
40 patients that received one or two level ACDF structural allograft with plates with autograft and /or allograft comprised of cancellous and/or corticocancellous bone chips.
Procedure: Structural allograft
20 patients who are receiving Tritanium C as standard of care.
Device: Tritanium C
Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips
Subjects will receive the Tritanium C anterior cervical cage which is intended to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Time frame: 3 months post-operatively
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Time frame: 6 months post-operatively
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Time frame: 12 months post-operatively
Neck disability
Neck Disability Index (NDI): Subjects will designate a statement that best describes their level of disability for each section of the survey. Statements are then ranked from 0-5, where 0 is a better outcome and 5 is a worse outcome. All rankings are totaled for a final score.
Time frame: Baseline, 3, 6, and 12 months post-operatively
Neck and arm pain
Visual Analog Scale (VAS) for neck and arm pain: Subjects will designate a score to represent their pain from 0 to 10. 0 is indicative of no pain and 10 is indicative of the worst possible pain.
Time frame: Baseline, 3, 6, and 12 months post-operatively
Incidence of sensory deficits
Yes or no response to: Sensory deficit at the surgical level, sensory deficit at an adjacent level to the surgical level, sensory deficit at a different level to the surgical level, any sensory deficit during follow-up
Time frame: Baseline, 3, 6, and 12 months post-operatively
Incidence of motor deficits
Yes or no response to: Motor deficit at the surgical level, motor deficit at an adjacent level to the surgical level, motor deficit at a different level to the surgical level, any motor deficit
Time frame: Baseline, 3, 6, and 12 months post-operatively
Rate of Adverse Events
Adverse Event assessment
Time frame: Day of surgery, 3, 6 and 12 month post-operatively
Started Aug 2020 (actual). Primary completion is estimated for Dec 2026, 76 months after the start.
Of 40 non-industry interventional studies with no phase under Intervertebral Disc Degeneration, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 63. This study's planned 76 months is above that.
Counting every sponsor, half of 85 studies reached it within 50 months; a quarter within 27 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intervertebral Disc Degeneration →
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)