A Prospective Randomized Study on Lumbar Posterior Interbody Fusion Using a Novel Titanium Intervertebral Implant accelerate functional fusion guiding oriented collagen and apatite and PEEK or Titanium-Coated PEEK Intervertebral Implants

JRCT ID: jRCTs042240095

Registered date:01/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lumbosacral disorders requiring lumbosacral intervertebral fusion
• Date of first enrollment: 01/10/2024
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Perform a single intervertebral posterior lumbar (sacral) intervertebral fusion. The assigned intervertebral implant will be used. In the control group, autologous local bone (spinous process, vertebral arch) will be grafted into the implant; in the UNIOS PL spacer intervention group, no bone will be grafted into the implant.

Outcome(s)

• Primary Outcome: Bone fusion in CT and radiographic images at 6 months postoperatively

Secondary Outcome

1. bone fusion at 3 months, 1 year, and 2 years postoperatively on CT and radiographic images
2. incidence of trabecular bone remodeling (osteosclerotic changes that are considered an indicator of bone union to the intervertebral implant) and bone cysts (predictors of bone union failure) in CT images at 3 months, 6 months, 1 year, and 2 years postoperatively
3. contact between intervertebral implants and adjacent endplates at 3 months, 6 months, 1 year, and 2 years postoperatively on CT
4. control group: status of allograft and adjacent endplate at 3 months, 6 months, 1 year, and 2 years postoperative CT
Intervention group: Evaluation of the presence of new bony bridges between vertebral bodies. 5.
5. comparison of the frequency of intervertebral implant subsidence into the vertebral body and screw loosening at 3 months, 6 months, 1 year, and 2 years postoperatively on CT
6. operative time, intraoperative blood loss
Clinical evaluation questionnaires (JOA-BPEQ, ODI)
8. revision surgery rate
9. frequency of adverse events
10. comparison of study subject background, age, gender, symptoms, interview (pre-existing medical conditions (especially osteoporosis fractures) complications, medications), physical examination: height, weight, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. patients diagnosed with lumbar spinal canal stenosis, lumbar spondylolisthesis, lumbar spondylolisthesis, lumbar spondylolisthesis, lumbar disc herniation, lumbar nerve root disease, lumbar disc disease, lumbar intervertebral foramen stenosis, scoliosis (posterior), or spinal fracture
2. stage, type, and condition (definition): Patients with local instability in the lumbosacral region requiring single posterior intervertebral fusion. 3. gender and age: 20 years old.
3. gender and age: 20 years of age or older, regardless of gender
4. patients whose consent to participate in this study has been obtained by signing a consent form in person

Exclude criteria

1. Patients who are not candidates for lumbosacral posterior intervertebral fusion
2. patients with a history of lumbosacral fusion
3. women who are pregnant or who wish to become pregnant during the study period
4. patients who are unable to give consent to participate in the study or complete the questionnaires due to physical or mental condition
5. patients who are deemed inappropriate by the treating physician
6. patients with severe osteoporosis
7. patients who are unable to give consent to participate in this study

Related Information

• Primary Sponsor: Hasegawa Tomohiko
• Secondary Sponsor: TEIJIN NAKASHIMA MEDICAL CO., LTD