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

NCT07739979 | Completed

• 1 other identifier: 87
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Spondylopathy

Keywords

anterior cervical discectomy and fusion; Polyetheretherketone; iliac crest

Outcome Measures

Primary Outcomes (3)

• Trabecular Bone Formation and Bridging Bone Formation

  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.

  6 Months

• Motion on Flexion-Extension X-rays

  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.

  6 Months

• Disc Height Score

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

  6 Months

Study Arms (2)

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

Interventions

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)

Group A participants underwent iliac crest auto graft

Polyetheretherketone (PEEK) cage DEVICE

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

Group B participants with Polyetheretherketone cage

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Services Hospital, Lahore: lead

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: February 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)