Clinical outcome and fusion rates after surgery with TM Ardis interbody fusion system

Phase 4

Completed

• Conditions: Degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis; Musculoskeletal Diseases; Spondylolisthesis

• Registration Number: ISRCTN89404187
• Lead Sponsor: Zimmer Spine (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-27
• Study Completion: 2018-05-31
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Age 18 years or over
2. Degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
3. ODI over or equal to 40/100
4. Back pain over or equal to 4/10
5. Mono segmental lumbosacral disease fulfilling the prior conditions: only one level between L2 and S1
6. Skeletally mature patients
7. Six months failed conservative treatment
8. Gave written consent to take part in the study by signing patient informed consent form
9. Physically and mentally able to comply with the protocol, including ability to read and complete required forms and adhere to the follow-up requirements of the protocol

Exclusion Criteria

1. Prior surgical procedure at the index level using the desired operative approach
2. Severe degenerative lesions at more than one level of the lumbosacral spine
3. Morbid obesity (BMI = 40)
4. Active local infection in or near the operative region
5. Active systemic infection and/or disease
6. Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation
7. Known or suspected sensitivity to the implant materials
8. Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)
9. Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs
10. Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
11. Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care
12. Pregnant
13. Unwilling to follow postoperative instructions, in particular with respect to athletic or occupational activities
14. Current vertebral metastatic tumors
15. Symptomatic cardiac disease
16. Severe congenital or acquired vertebral deformities

Study & Design

• Study Type: Observational
• Study Design: Not specified