Cervical DeformityPCDNCT01588054
Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity
An observational study of Cervical Deformity and Kyphosis, run by International Spine Study Group Foundation at 10 sites in United States.
Trial summary
The purpose of this study is to define clinical and demographic features within the population suffering from cervical deformity to assist health professionals to make important treatment decisions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Deformity, Kyphosis, Scoliosis
- How many people
- 100 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 Jan 2013to Jun 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: spine surgeon clinic
Who may be able to join
- Adult 18 years of age or greater
- Cervical deformity (kyphosis C2-7 greater than 10 degrees or scoliosis with coronal cobb greater than 10 degrees)
- Plans for surgical correction of cervical deformity
Who cannot join
- Active tumor or infection
- Acute trauma
- Unwillingness to provide consent or complete study forms
- Prisoner
- Pregnant or planning to get pregnant during study period
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Virginia
Charlottesville, Virginia, 22908
Denver International Spine Center
Denver, Colorado, 80128
University of Kansas Medical Center
Kansas City, Kansas, 66160
Scripps Clinic La Jolla
La Jolla, California, 92037
New York University - Hospital for Joint Diseases
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
Baylor Scoliosis Center
Plano, Texas, 75093
University of California - Davis
Sacramento, California, 95817
University of California - San Francisco Medical Center
San Francisco, California, 94143
Washington University
St Louis, Missouri, 63110
About this study
Official title: Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study
The purpose of this study is to define clinical and demographic features within the population suffering from cervical deformity to assist health professionals to make important treatment decisions.
- Conditions
- Cervical Deformity, Kyphosis, Scoliosis
- Medical subject headings
- Kyphosis, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adults, cervical deformity, surgical treatment | Adults 18years or older at time of enrollment, cervical deformity to include kyphosis (C2-7 greater than 10 degrees) or scoliosis (coronal cobb greater than 10 degrees), plans for surgical treatment of cervical deformity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographs
Changes in the degree of deformity post surgical correction and assessment of fusion.
Measured: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Secondary outcomes (5)
Neck Disability Index (NDI)
Changes related to worsening/improved neck pain as regards ability to manage everyday life.
Measured: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Numeric rating scale (NRS)
Changes in level of neck and back pain within the past month
Measured: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
CSRS SWAL-QOL
Changes with swallowing problems affecting day-to-day quality of life
Measured: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
EQ-5D3L
Changes in current health state
Measured: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
mJOA
Changes in neck pain regarding ability fo function in everyday life
Measured: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study start9 Jan 2013
- Primary completion8 May 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical DeformityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Spine Study Group Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Spine
- Responsible party
- Sponsor
- Investigators
- Justin Smith, MD, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588054
- Sponsor's protocol ID
- 2107-01
- Acronym
- PCD
- Status last verified
- Oct 2023
- First submitted
- 24 Apr 2012
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith JS, Ben-Israel D, Kelly MP, Lafage V, Lafage R, Klineberg EO, Kim HJ, Line B, Protopsaltis TS, Passias P, Eastlack RK, Mundis GM, Riew KD, Kebaish K, Park P, Gupta MC, Gum JL, Daniels AH, Diebo BG, Hostin R, Scheer JK, Soroceanu A, Hamilton DK, Buell TJ, Lewis SJ, Lenke LG, Mullin JP, Schwab FJ, Burton D, Shaffrey CI, Ames CP, Bess S. The gap between surgeon goal and achieved sagittal alignment in adult cervical spine deformity surgery. J Neurosurg Spine. 2025 Jan 3;42(3):309-319. doi: 10.3171/2024.8.SPINE24703. Print 2025 Mar 1.
PubMed 39752660
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study
- ClinicalTrials.gov ID
- NCT01588054
- Acronym / sponsor ID
- PCD / 2107-01
- Conditions
- Cervical Deformity, Kyphosis, Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- International Spine Study Group FoundationUniversity, hospital or other
- Collaborators
- DePuy Spine
- Study start
- 9 Jan 2013 (actual)
- Primary completion
- 8 May 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 30 Apr 2012 (estimated)
- 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 purpose of this study is to define clinical and demographic features within the population suffering from cervical deformity to assist health professionals to make important treatment decisions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults, cervical deformity, surgical treatment | – | –Adults 18years or older at time of enrollment, cervical deformity to include kyphosis (C2-7 greater than 10 degrees) or scoliosis (coronal cobb greater than 10 degrees), plans for surgical treatment of cervical deformity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- spine surgeon clinic
Key inclusion criteria (3 listed)
- Adult 18 years of age or greater
- Cervical deformity (kyphosis C2-7 greater than 10 degrees or scoliosis with coronal cobb greater than 10 degrees)
- Plans for surgical correction of cervical deformity
Key exclusion criteria (5 listed)
- Active tumor or infection
- Acute trauma
- Unwillingness to provide consent or complete study forms
- Prisoner
- Pregnant or planning to get pregnant during study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographs
Time frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Changes in the degree of deformity post surgical correction and assessment of fusion.
5 secondary outcomes
Neck Disability Index (NDI)
Time frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Numeric rating scale (NRS)
Time frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
CSRS SWAL-QOL
Time frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
EQ-5D3L
Time frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
mJOA
Time frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
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 12 Oct 2023.
- Derived from this study: PubMed 39752660Smith JS, Ben-Israel D, Kelly MP, Lafage V, Lafage R, Klineberg EO, Kim HJ, Line B, Protopsaltis TS, Passias P, Eastlack RK, Mundis GM, Riew KD, Kebaish K, Park P, Gupta MC, Gum JL, Daniels AH, Diebo BG, Hostin R, Scheer JK, Soroceanu A, Hamilton DK, Buell TJ, Lewis SJ, Lenke LG, Mullin JP, Schwab FJ, Burton D, Shaffrey CI, Ames CP, Bess S. The gap between surgeon goal and achieved sagittal alignment in adult cervical spine deformity surgery. J Neurosurg Spine. 2025 Jan 3;42(3):309-319. doi: 10.3171/2024.8.SPINE24703. Print 2025 Mar 1.
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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.
Justin Smith, MD, PhD principal investigator
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Deformity and Kyphosis, run by International Spine Study Group Foundation at 10 sites in United States.
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 3 inclusion and 5 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Radiographs (time frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01588054, which also lists 1 linked publication.
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 12 Oct 2023.