Cervical SpondylopathyNCT07739979
Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical Spondylosis
A study testing Anterior Cervical Dissectomy and Fusion using Iliac crest autograft and Polyetheretherketone (PEEK) cage in people with Cervical Spondylopathy, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cervical Spondylopathy
- What is being tested?
- Anterior Cervical Dissectomy and Fusion using Iliac crest autograft and Polyetheretherketone (PEEK) cage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Anterior Cervical Dissectomy and Fusion using Iliac crest autograft, Polyetheretherketone (PEEK) cage
- Keywords
- anterior cervical discectomy and fusion, Polyetheretherketone, iliac crest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cervical Dissectomy and Fusion using Iliac crest autograftProcedure or surgery
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) cageDevice
In group B, PEEK (Polyetheretherketone) cage and plating were used
| Study group | Role | What they receive |
|---|---|---|
| Group B participants with Polyetheretherketone cage | Active comparator | Not described Receives: Device: Polyetheretherketone (PEEK) cage |
| Group A participants underwent iliac crest auto graft | Experimental | Not described Receives: Procedure: Anterior Cervical Dissectomy and Fusion using Iliac crest autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Feb 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sohaib Ashraf, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739979
- Sponsor's protocol ID
- 87
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT07739979
- Acronym / sponsor ID
- 87
- Conditions
- Cervical Spondylopathy
- Keywords
- anterior cervical discectomy and fusion, Polyetheretherketone, iliac crest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Cervical Dissectomy and Fusion using Iliac crest autograftAfter 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) | Procedure or surgery | Group A participants underwent iliac crest auto graft |
| Polyetheretherketone (PEEK) cageIn group B, PEEK (Polyetheretherketone) cage and plating were used | Device | Group B participants with Polyetheretherketone cage |
Primary outcome
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Cervical Dissectomy and Fusion using Iliac crest autograft and Polyetheretherketone (PEEK) cage in people with Cervical Spondylopathy, run by Services Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trabecular Bone Formation and Bridging Bone Formation (time frame: 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.