ScoliosisNCT00890227
Incidence of Proximal Junctional Kyphosis (PJK) in Long Posterior Spinal Fusion: A Study Comparing Traditional Open Surgery to Minimally Invasive Percutaneous Technique at the Proximal Fusion Levels
A study testing Traditional technique and Minimally invasive technique in people with Scoliosis and Kyphosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to compare two methods of surgery to treat scoliosis and/or kyphosis of the spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Traditional technique and Minimally invasive technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals presenting for surgical correction of scoliosis and/or kyphosis of the thoracolumbar spine are the primary target for enrollment.
- Men and women ages 18 years or older will be eligible for participation in the current study.
- In addition, individuals must be able to provide informed consent (Mini-Mental State Examination score of at least 18/30).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
About this study
Official title: Incidence of Proximal Junctional Kyphosis (PJK) in Long Posterior Spinal Fusion: A Prospective Controlled Randomized Study Comparing Traditional Open Surgery to Minimally Invasive Percutaneous Technique at the Proximal Fusion Levels/Levels
This research is being done to compare two methods of surgery to treat scoliosis and/or kyphosis of the spine.
Read the detailed description
Currently, there are two different surgical methods used in the treatment of these problems. One method includes an all open posterior spinal fusion (large incision with opening of the muscles); this is also known as a traditional technique. The second method involves an open surgery for the portion of the spine requiring a fusion except the very top area, where minimally invasive technique (smaller incision and without opening of the muscles) is used.
One possible side effect of either method for surgical repair is a condition called proximal junctional kyphosis (PJK). PJK occurs in the form of fracture at the top vertebra involved in the surgery or as a loss of correction of spinal alignment achieved, through gradual bending forward of the spine over time. In this study we want to compare the rate of PJK between two groups of patients undergoing long posterior spinal instrumentation fusion.
People undergoing long posterior spinal instrumented fusion may join.
About 68 people will join.
- Being tested
- Traditional technique, Minimally invasive technique
- Keywords
- scoliosis, kyphosis, Surgical treatment
- Medical subject headings
- Scoliosis, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional techniqueProcedure or surgery
All level open instrumented posterior spinal fusions
Minimally invasive techniqueProcedure or surgery
Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.
| Study group | Role | What they receive |
|---|---|---|
| Traditional technique | Active comparator | All level open instrumented posterior spinal fusions Receives: Procedure: Traditional technique |
| Minimally invasive technique | Active comparator | Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used. Receives: Procedure: Minimally invasive technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups.
rate of proximal junctional fracture or instrumentation failure
Measured: 12 months
Secondary outcomes (6)
To evaluate complication rate between the two groups.
rate of complications
Measured: 3 months
To compare the total operative time between the two groups of surgical patients (as stratified above).
operative time
Measured: 12 months
To compare the length of hospital stay between the two groups of surgical patients (as stratified above).
length of hospital stay
Measured: 12 months
To compare the total recovery time between the two groups of surgical patients (as stratified above).
total recovery time
Measured: 12 months
To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above).
pain rating
Measured: 12 months
To assess change in self-reported functional limitations following surgery between two groups of surgical patients (as stratified above).
oswestry disability index
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled M Kebaish, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890227
- Sponsor's protocol ID
- NA_00002729
- Other IDs
- SORC_KMK_08_006
- Status last verified
- Dec 2018
- First submitted
- 27 Apr 2009
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Proximal Junctional Kyphosis (PJK) in Long Posterior Spinal Fusion: A Prospective Controlled Randomized Study Comparing Traditional Open Surgery to Minimally Invasive Percutaneous Technique at the Proximal Fusion Levels/Levels
- ClinicalTrials.gov ID
- NCT00890227
- Acronym / sponsor ID
- NA_00002729
- Keywords
- scoliosis, kyphosis, Surgical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 Apr 2009 (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.
This research is being done to compare two methods of surgery to treat scoliosis and/or kyphosis of the spine.
Detailed description
Currently, there are two different surgical methods used in the treatment of these problems. One method includes an all open posterior spinal fusion (large incision with opening of the muscles); this is also known as a traditional technique. The second method involves an open surgery for the portion of the spine requiring a fusion except the very top area, where minimally invasive technique (smaller incision and without opening of the muscles) is used.
One possible side effect of either method for surgical repair is a condition called proximal junctional kyphosis (PJK). PJK occurs in the form of fracture at the top vertebra involved in the surgery or as a loss of correction of spinal alignment achieved, through gradual bending forward of the spine over time. In this study we want to compare the rate of PJK between two groups of patients undergoing long posterior spinal instrumentation fusion.
People undergoing long posterior spinal instrumented fusion may join.
About 68 people will join.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional technique | Active comparator | Procedure: Traditional techniqueAll level open instrumented posterior spinal fusions |
| Minimally invasive technique | Active comparator | Procedure: Minimally invasive techniqueOpen surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals presenting for surgical correction of scoliosis and/or kyphosis of the thoracolumbar spine are the primary target for enrollment.
- Men and women ages 18 years or older will be eligible for participation in the current study.
- In addition, individuals must be able to provide informed consent (Mini-Mental State Examination score of at least 18/30).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Traditional techniqueAll level open instrumented posterior spinal fusions | Procedure or surgery | Traditional technique |
| Minimally invasive techniqueOpen surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used. | Procedure or surgery | Minimally invasive technique |
Primary outcome
To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups.
Time frame: 12 months
rate of proximal junctional fracture or instrumentation failure
6 secondary outcomes
To evaluate complication rate between the two groups.
Time frame: 3 months
To compare the total operative time between the two groups of surgical patients (as stratified above).
Time frame: 12 months
To compare the length of hospital stay between the two groups of surgical patients (as stratified above).
Time frame: 12 months
To compare the total recovery time between the two groups of surgical patients (as stratified above).
Time frame: 12 months
To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above).
Time frame: 12 months
To assess change in self-reported functional limitations following surgery between two groups of surgical patients (as stratified above).
Time frame: 12 months
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 19 Dec 2018.
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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.
Khaled M Kebaish, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional technique and Minimally invasive technique in people with Scoliosis and Kyphosis, run by Johns Hopkins University at 1 site 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 0 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 19 Dec 2018. 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 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?
To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups. (time frame: 12 months). 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 19 Dec 2018.