Scoliosis IdiopathicNCT04538092
Complex Spine Enhanced Recovery After Surgery (ERAS)
A study testing Enhanced Recovery After Surgery Protocol in people with Scoliosis Idiopathic, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Enhanced Recovery After Surgery Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 1 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) Scoliosis (M41.9) category.
- Patients undergoing a > 5 level arthrodesis using one of the following Current Procedural Terminology (CPT) coded procedures 22534, 22585, 22614, 22632, 22634 with either 22842, 22853
- Cobb angle > 10 degrees
- Failure of 3 months of conservative management
Who cannot join
- Prior scoliosis surgery not performed at UNC Chapel Hill Hospital Facilities
- Deformity correction due to trauma
- History of neoplastic spine disease
- Patients with active osteomyelitis
- Patients with prior cement augmentation.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Chapel Hill Hospital
Chapel Hill, North Carolina, 27514
About this study
Official title: Single Institution Prospective Analysis of an Enhanced Recovery After Complex Spine Surgery Protocol
In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.
Read the detailed description
Purpose : In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.
Participants : Patients undergoing surgery aimed at treating adult spinal deformity are the subject of this research. This population was chosen as these procedures are often associated with prolonged length of stay (LOS), high post-operative narcotic use, and often require complex post-operative discharge planning.
Procedures : Patients undergoing surgery to address the complications of ASD present a unique challenge in that this patient population is diverse, and there are multiple operative procedures available to treat the same condition. Given that there are currently no accepted or recommended Enhanced Recovery After Surgery protocols for complex spine procedures, the investigators have developed an ERAS protocol at the University of North Carolina (UNC) in collaboration with the anesthesia department for the support of complex surgical patients.
Hypothesis: Implementing a multi-modal enhanced recovery after complex spine surgery protocol will improve patient measured outcomes and patient functional outcomes leading to a statistically significant reduction in LOS, post-operative pain, complication rate, cost.
- Conditions
- Scoliosis Idiopathic
- Being tested
- Enhanced Recovery After Surgery Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery ProtocolOther
Also called Preoperative education, Preoperative nutrition, Intraoperative analgesia, Intraoperative fluid resuscitation
The investigators have developed an Enhanced Recovery After Surgery protocol for complex spine surgery at UNC. This study will help elucidate the effects of multiple interventions tailored to help patients recover from complex surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard post op complex spine orders placed for patients undergoing deformity correction |
| ERAS | Experimental | Enhanced recovery after surgery protocol is applied to the patients undergoing deformity correction Receives: Other: Enhanced Recovery After Surgery Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Number of nights spent in the hospital following surgery
Measured: From conclusion of surgery to hospital discharge, an expected average of 10 days
Secondary outcomes (19)
Narcotic usage
Total morphine milligram equivalents (MME) utilized while inpatient and after discharge
Measured: From conclusion of surgery to 12 months
30 Day Readmission
Did the patient require a repeat hospitalization within 30 days after the initial surgery?
Measured: From day of hospital discharge to 30 days
90 Day Readmissions
Did the patient require a repeat hospitalization within 90 days after the initial surgery
Measured: From day of hospital discharge to 90 days
30 Day Reoperations
Did the patient require a repeat reoperation within 30 days after the initial surgery
Measured: From day of hospital discharge to 30 days
Change in Oswestry Disability Index Score from Pre-op baseline.
The Oswestry Disability Index (ODI) for functional impairment is used to quantify disability related to lower back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Higher scores reflect more severe disability.
The Oswestry Disability Index (ODI) measures patients' degree of disability related to lower back pain. The ODI has 10 items (Pain, self-care, bring, walking, sitting, standing, sleeping, sex, social, and travelling). After adding up the total score of each item, the initial total score is 0 to 50 points. Then divide the total score by 5 and multiply by 20 to get the final score of 0 to 100.
Measured: Preop to post op comparison of ODI at 4 days, 2 weeks, 6 weeks, 12 weeks and 6 months.
Promis Score - Pain
Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured.
Measured: Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
Promis Score - Physical Activity
Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured.
Measured: Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
Promis Score - Physical Function
Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured.
Measured: Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
Time to mobilization
The amount of time needed from the completion of surgery until the patient is ambulating out of bed
Measured: From the end of surgery until the date of hospital discharge, assessed up to 1 month.
Time to oral intake
The amount of time needed from the completion of surgery until the patient is able to take food or drink orally
Measured: From the end of surgery until the date of oral intake, assessed up to 2 weeks.
Change in Coronal Cobb Angle
Standard radiographic description of standing scoliosis x-ray made using the Cobb angle measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months
Measured: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Degrees of Apical Vertebra Rotation
Standard radiographic description of the change between standing scoliosis x-ray made using the Apical Vertebra's Rotation measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months
Measured: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Thoracic Kyphosis (TK)
Standard radiographic description of standing scoliosis x-ray made using the Thoracic Kyphosis (TK) measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months
Measured: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Lumbar Lordosis (LL)
Standard radiographic description of standing scoliosis x-ray made using the Lumbar Lordosis (LL) measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months
Measured: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Sacral Slope (SS)
Standard radiographic description of standing scoliosis x-ray made using the Sacral Slope (SS) measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months
Measured: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Pelvic Tilt (PT)
Standard radiographic description of standing scoliosis x-ray made using the Pelvic Tilt (PT) measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months
Measured: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Pelvic Incidence (PI)
Standard radiographic description of standing scoliosis x-ray made using the Pelvic Incidence (PI) measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months
Measured: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Sagittal Vertical Axis (SVA) Measurement
Sagittal Vertical Axis (SVA) measurement assessed using standing scoliosis x-ray and reported in centimeters
Measured: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Coronal Imbalance Measurement
Coronal Imbalance measurement assessed using standing scoliosis x-ray and reported in centimeters
Measured: Within 6 months pre-operatively and up to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start14 Sep 2020
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Why it stopped: PI moved to different institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Spine Society
- Responsible party
- Sponsor
- Investigators
- Andrew Abumoussa, MD MSc, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538092
- Sponsor's protocol ID
- 20-1705
- Status last verified
- Oct 2022
- First submitted
- 20 Aug 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Institution Prospective Analysis of an Enhanced Recovery After Complex Spine Surgery Protocol
- ClinicalTrials.gov ID
- NCT04538092
- Acronym / sponsor ID
- 20-1705
- Conditions
- Scoliosis Idiopathic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moved to different institution
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Spine Society
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 3 Sep 2020 (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.
In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.
Detailed description
Purpose : In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.
Participants : Patients undergoing surgery aimed at treating adult spinal deformity are the subject of this research. This population was chosen as these procedures are often associated with prolonged length of stay (LOS), high post-operative narcotic use, and often require complex post-operative discharge planning.
Procedures : Patients undergoing surgery to address the complications of ASD present a unique challenge in that this patient population is diverse, and there are multiple operative procedures available to treat the same condition. Given that there are currently no accepted or recommended Enhanced Recovery After Surgery protocols for complex spine procedures, the investigators have developed an ERAS protocol at the University of North Carolina (UNC) in collaboration with the anesthesia department for the support of complex surgical patients.
Hypothesis: Implementing a multi-modal enhanced recovery after complex spine surgery protocol will improve patient measured outcomes and patient functional outcomes leading to a statistically significant reduction in LOS, post-operative pain, complication rate, cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard post op complex spine orders placed for patients undergoing deformity correction |
| ERAS | Experimental | Other: Enhanced Recovery After Surgery ProtocolEnhanced recovery after surgery protocol is applied to the patients undergoing deformity correction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) Scoliosis (M41.9) category.
- Patients undergoing a > 5 level arthrodesis using one of the following Current Procedural Terminology (CPT) coded procedures 22534, 22585, 22614, 22632, 22634 with either 22842, 22853
- Cobb angle > 10 degrees
- Failure of 3 months of conservative management
Key exclusion criteria (5 listed)
- Prior scoliosis surgery not performed at UNC Chapel Hill Hospital Facilities
- Deformity correction due to trauma
- History of neoplastic spine disease
- Patients with active osteomyelitis
- Patients with prior cement augmentation.
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 |
|---|---|---|
| Enhanced Recovery After Surgery ProtocolAlso: Preoperative education, Preoperative nutrition, Intraoperative analgesia, Intraoperative fluid resuscitationThe investigators have developed an Enhanced Recovery After Surgery protocol for complex spine surgery at UNC. This study will help elucidate the effects of multiple interventions tailored to help patients recover from complex surgery. | Other | ERAS |
Primary outcome
Length of Stay
Time frame: From conclusion of surgery to hospital discharge, an expected average of 10 days
Number of nights spent in the hospital following surgery
19 secondary outcomes
Narcotic usage
Time frame: From conclusion of surgery to 12 months
30 Day Readmission
Time frame: From day of hospital discharge to 30 days
90 Day Readmissions
Time frame: From day of hospital discharge to 90 days
30 Day Reoperations
Time frame: From day of hospital discharge to 30 days
Change in Oswestry Disability Index Score from Pre-op baseline.
Time frame: Preop to post op comparison of ODI at 4 days, 2 weeks, 6 weeks, 12 weeks and 6 months.
Promis Score - Pain
Time frame: Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
Promis Score - Physical Activity
Time frame: Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
Promis Score - Physical Function
Time frame: Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
Time to mobilization
Time frame: From the end of surgery until the date of hospital discharge, assessed up to 1 month.
Time to oral intake
Time frame: From the end of surgery until the date of oral intake, assessed up to 2 weeks.
Change in Coronal Cobb Angle
Time frame: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Degrees of Apical Vertebra Rotation
Time frame: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Thoracic Kyphosis (TK)
Time frame: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Lumbar Lordosis (LL)
Time frame: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Sacral Slope (SS)
Time frame: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Pelvic Tilt (PT)
Time frame: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Pelvic Incidence (PI)
Time frame: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Sagittal Vertical Axis (SVA) Measurement
Time frame: Within 6 months pre-operatively and up to 6 months postoperatively
Change in Coronal Imbalance Measurement
Time frame: Within 6 months pre-operatively and up to 6 months postoperatively
Results and safety
The study was stopped early (reason given: PI moved to different institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Andrew Abumoussa, MD MSc principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery Protocol in people with Scoliosis Idiopathic, run by University of North Carolina, Chapel Hill 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 4 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: stopped early, as of the sponsor's last update on 18 Nov 2023. 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 was stopped early (reason given: PI moved to different institution). Results are not available in the source record.
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?
Length of Stay (time frame: From conclusion of surgery to hospital discharge, an expected average of 10 days). 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 18 Nov 2023.