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OpenTrials
Completed

NCT Number: NCT07739979

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

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.

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Key information

Conditions

Cervical Spondylopathy

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anterior Cervical Dissectomy and Fusion using Iliac crest autograft

Procedure

After receiving written informed consent, name, age, gender, and sickness duration, demographic factors were also documented. 21 participants underwent bone transplant, plating, and ACDF (anterior cervical discectomy and fusion)

Polyetheretherketone (PEEK) cage

Device

In group B, PEEK (Polyetheretherketone) cage and plating were used

Primary outcomes

  1. Trabecular Bone Formation and Bridging Bone Formation

    Time frame: 6 Months

    Trabecular bone is the formation of bone between graft and end plates of superior and inferior vertebrae.It was noted at 1, 3 and 6th Month.

  2. Motion on Flexion-Extension X-rays

    Time frame: 6 Months

    Motion of the spinous process of <2mm is marked as fused, while a distance of > 2 mm between spinous processes on flexion and extension X-rays is marked as unfused.

  3. Disc Height Score

    Time frame: 6 Months

    Disc height was observed as distance between endplates and >25% reduction in disc height from postoperative X-rays were noted as unfused

Sponsors and collaborators

Lead sponsor

Services Hospital, Lahore

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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