ClinConnect ClinConnect Logo
Search / Trial NCT05963815

The Spine PROMCO Study

Launched by PARK MEDICAL CENTRUM · Jul 19, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Patient Related Outcome Measures Prognosis Degenerative Spine Disease

ClinConnect Summary

The Spine PROMCO Study is a research trial looking at how different surgical treatments help people with problems in their lower back, specifically conditions like herniated discs, spinal stenosis, and spondylolisthesis. The goal is to understand how effective these surgeries are for patients who need elective surgery (planned rather than emergency) for these issues. The study is currently recruiting participants aged between 65 and 74 years and also younger adults from 29 to 219 years old. Anyone interested must be able to complete an online questionnaire and have imaging tests, like MRIs, confirming their back condition.

To participate, you should have a degenerative disorder of the lumbar spine that requires surgery, such as a herniated disc or spinal stenosis, and you should be able to understand and fill out the study forms in Dutch. Unfortunately, those who cannot read or speak Dutch, or who have more serious issues like fractures or infections in the spine, won't be eligible for this study. If you join, you'll be asked to complete some online questionnaires about your condition and recovery, which will help researchers learn more about the effectiveness of these surgeries.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All patients who are eligible for elective surgery of the lumbar spine.
  • All patients with degenerative disorder of the lumbar spine including: herniated disk, stenosis, discopathy and spondylolisthesis.
  • Patients must be able to fill in the questionnaire online
  • Patients with imaging (Magnetic resonance imaging (MRI)) confirmed lumbar disc herniation, stenosis, discopathy, or listhesis.
  • Elective cases
  • Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.
  • Exclusion Criteria:
  • Patients who cannot speak nor read the Dutch language
  • Patients who are not able to complete the digital questionnaires, according to the including doctor
  • Patients with fractures, primary infections of the spine, or with spinal malignant- cies.
  • Patients in a traumatic setting.

About Park Medical Centrum

Park Medical Centrum is a leading clinical trial sponsor dedicated to advancing medical research and improving patient outcomes. With a focus on innovative therapies and cutting-edge treatments, the organization collaborates with healthcare professionals and research institutions to conduct rigorous clinical studies across various therapeutic areas. Park Medical Centrum adheres to the highest ethical standards and regulatory guidelines, ensuring the safety and well-being of participants while striving to bring transformative solutions to market. Committed to excellence in research and development, Park Medical Centrum plays a pivotal role in the evolution of healthcare.

Locations

Rotterdam, Zuid Holland, Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported