Indication and Treatment of Adult Kyphoscoliosis

NCT04536909 | Active Not Recruiting

• 1 other identifier: 1126
• Study Type: observational
• Target: 120
• Locations: 3 countries
• Sites: 5

Brief Summary

Degeneration, iatrogenic-/idiopathic causes and fractures can lead to kypho- scoliotic deformities potentially resulting in pain and loss of function. The surgical strategies rely on surgeon preferences and type of deformity as well as clinical symptoms. The complication rate of surgical treatment is high. The aim of this study is to elucidate the indications for surgical treatment of kyphoscoliosis and evaluate the effectiveness of surgical and non-surgical outcome clinically and radiologically. The primary outcome for the PROMs and x-ray is at 12 months, but the investigators will also follow the patients with the PROMs and x-rays after 2,5 and 10 years.

Conditions

Kyphoscoliosis

Keywords

deformity; spine; kyphosis; scoliosis

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI)

  One of the principal condition-specific outcome measures for spinal disorders. Scale from 0-100%, high scores equales increasing disability; 0-20% minimal disability, 20-40% moderat disability, 40-60% severe disability, 60-80% crippled, 80-100% bed bound or exaggerating their symptoms.

  12 months

Secondary Outcomes (5)

• Euroqol (EQ-5D)

  12 months

• Numeric rating scale (NRS)

  12 months

• Scoliosis research society (SRS22)

  12 months

• Lumbar stiffness disability index(LSDI)

  12 months

• Urination- and sexual function (USF)

  12 months

Study Arms (2)

Non-surgical

A non-surgical group for comparison, they will conduct a training program tailored for the kyphoscoliotic patients. The inclusion criteria is the same as for the surgical group.

Other: Non-surgical

Surgical

Patients operated with correction of kyphotic- or scoliotic deformity.

Procedure: Surgical

Interventions

Non-surgical OTHER

We have constructed a training program with help from physiotherapists from Rikshospitalet in Oslo, tailored for kyphotic- and scoliotic patients.

Non-surgical

Surgical PROCEDURE

Surgery for correction of kyphotic- or scoliotic deformity.

Surgical

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the age of 25 and older are included in the study, if they have a deformed spine that fulfil the inclusin criteria and non of the exclusion criteria. The patients are selected from the outpatient clinic in the including university hospitals (Area of Kyoto in Japan, Örebro in Sweden and the vestcoast as well as the souteast area of Norway).

You may qualify if:

• Out of coronar or sagittal balance: A correction of 20 degrees or more is possible due to the degree of degeneration.
• \>25 years
• \>30% ODI score

You may not qualify if:

• Do not want to participate and not able to answer PROMs
• Acute fractures (not healed fractures)
• Disc prosthesis
• Neuromuscular cause of deformity (the investigators include Parkinson patients)
• Activ infection or malignancy
• Ideopatic scoliosis with typical add on (the investigators include those that have \<20 degrees of scoliosis at Risser 5 and/or the scoliosis increase in age due to degeneration). If unknown, the patient will be included as a de novo scoliosis.

Sponsors & Collaborators

• University of Bergen: lead
• Oslo University Hospital: collaborator
• Kyoto University Hospital: collaborator
• Region Örebro County: collaborator
• Skane University Hospital: collaborator
• Haukeland University Hospital: collaborator

Study Sites (5)

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Ullevål University Hospital

Oslo, 0450, Norway

Location

Malmö University Hospital

Malmo, Skåne County, 2014 28, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Related Publications (45)

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MeSH Terms

Conditions

Congenital Abnormalities; Kyphosis; Scoliosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Stephan M Rohrl, PhD

  Oslo University Hospital Ullevåll

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: September 3, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); SE (2); NO (2)