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

NCT07739979 — Not applicable, Completed, 42 participants, Services Hospital, Lahore

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Registry	NCT07739979
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	42 (Actual)
Sponsor	Services Hospital, Lahore (Other gov)
Conditions	Cervical Spondylopathy
Interventions	Anterior Cervical Dissectomy and Fusion using Iliac crest autograft, Polyetheretherketone (PEEK) cage (Procedure, device)
Dates	start 2022-02-01, primary completion 2023-03-31, completion 2023-03-31, first posted 2026-07-31, last updated 2026-07-31
Locations	1 site in Pakistan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group B participants with Polyetheretherketone cage	Active comparator	Device: Polyetheretherketone (PEEK) cage
Group A participants underwent iliac crest auto graft	Experimental	Procedure: Anterior Cervical Dissectomy and Fusion using Iliac crest autograft

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

+Outcome measures

Primary outcomes

Trabecular Bone Formation and Bridging Bone Formation [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.
Motion on Flexion-Extension X-rays [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.
Disc Height Score [6 Months]: Disc height was observed as distance between endplates and >25% reduction in disc height from postoperative X-rays were noted as unfused

+Eligibility

Sex: All, ages: 20 Years to 60 Years

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

+Locations (1)

Facility	City	Country	Status
Services Hospital Lahore	Lahore, Punjab Province	Pakistan