CompletedNot Applicable

Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical Spondylosis

Pakistan42 participantsStarted 2022-02-01

Plain-language summary

The cervical spine is the most mobile portion of the spine and is more prone to degenerative spine changes like cervical disc herniation, cervical spine stenosis, ossified posterior longitudinal ligament and osteophyte formation. Cervical spondylosis describes a variety of progressive degenerative changes that affect all components of the cervical spine (i.e., intervertebral discs, facet joints, Luschka joints, ligamentum flavum, and lamina). This is a normal aging process that affects most people in their 50's. Due to its stability, ACDF (anterior cervical discectomy and fusion) employing an iliac crest auto-graft is regarded as best, but it carries significant donor-site morbidity, hematoma formation, infection and pain etc. These morbidities leads to development of newer techniques, such as a PEEK cage. This technique lacks donor site morbidity but it is not cost-effective. The purpose of this study is to compare bony fusion between two of the most common fusion grafts: iliac crest auto-graft and PEEK(Polyetheretherketone) cage allograft, among patients undergoing ACDF in the Neurosurgical facility of Services Hospital, Lahore.

Who can participate

Age range

20 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: In our study, patients were included with an age of 20- 60 years, both male and female, and having one level of disc disorder between C3-C7 with radiculopathy/myelopathy, no previous ACDF Surgery, and Cervical Spine traumatic injury. Exclusion Criteria: Patients who had previous cervical spine surgery, having more than one level of pathology, patients who needed posterior instrumentation, having infection/Caries Spine/Osteomyelitis etc. and having malignancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Trabecular Bone Formation and Bridging Bone Formation

Timeframe: 6 Months

Motion on Flexion-Extension X-rays

Timeframe: 6 Months

Disc Height Score

Timeframe: 6 Months

Trial details

NCT IDNCT07739979

SponsorServices Hospital, Lahore

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-03-31

View on ClinicalTrials.gov More Cervical Spondylopathy trials

Plain-language summary

Who can participate

Age range

20 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.