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The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases. This study is supporting the clinical evaluation report. From the standard-of-care perspective, the results of The Degen study are expected to contribute to a better understanding of expected safety and clinical outcomes from a short (intra- and peri-operative) to a medium-term follow-up (post-operatively).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PASS LP implants | Patient suffering from a spinal degenerative disease and who is operated with PASS LP |
| |
| PASS Degen implants | Patient suffering from a spinal degenerative disease and who is operated with PASS DEGEN |
| |
| PASS Tulip PRIME implants | Patient suffering from a spinal degenerative disease and who is operated with PASS TULIP PRIME |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PASS LP implants | Device | Thoraco lumbar arthrodesis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant Who Achieved Their Fusion at 24 Months | The primary endpoint is the fusion status of each patient at the 24-month visit postoperative. This fusion assessment will be done through the analysis of the standard of care imaging (CT-scan, X-rays, and/or MRI) by the investigator and through the clinical examination of the patient by the investigator. | At 24months |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the Pain (VAS) | Change of leg and back pain score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 10 (worst) | Preoperative, and 1-6, 12 and 24 months postoperative |
| Quality of Life With ODI |
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Inclusion Criteria:
Exclusion Criteria:
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All patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique du Dos Bordeaux - Terrefort | Bruges | 33520 | France | |||
| Clinique des Cèdres |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18201937 | Background | Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008 Nov-Dec;8(6):968-74. doi: 10.1016/j.spinee.2007.11.006. Epub 2008 Jan 16. | |
| 12592542 |
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Only subjects implanted with one of 3 products listed in the protocol can included and considered as participant. Knowing that 1 investigational site corresponds to only one type of products used.
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| ID | Title | Description |
|---|---|---|
| FG000 | PASS DEGEN | Correspond to all subjects implanted with the PASS DEGEN |
| FG001 | PASS LP | Correspond to all subjects implanted with the PASS LP |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2024 | Apr 10, 2026 |
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| PASS DEGEN |
| Device |
Thoraco lumbar arthrodesis |
|
| PASS TULIP PRIME | Device | Thoraco lumbar arthrodesis |
|
Change of non-validated ODI score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 50 (worst)
| Preoperative, and 1-6, 12 and 24 months postoperative |
| Quality of Life With SF-12 | Change of non-validated SF-12 score from the preoperative visit to all available postoperative timepoints: from to 0 (better) to 5 (worst) by question, then questions are combined following the SF12 provider recommendation. The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS and MCS can be between O and 100. | Preoperative, and 1-6, 12 and 24 months postoperative |
| Surgeons'Satisfaction With These Implants and Instruments | Surgeons will be requested to complete questions about device/surgery satisfaction. | During the surgery and until the 24months postoperative visit |
| Fusion Status at the 1/6 Month and 12-month Visit | The primary objective is defined as the ability of the implant to promote the stabilization | At the 1-6, and 12 months postoperative |
| Patient Satisfaction at All Available Postoperative Timepoints | Patient satisfaction is used to evaluate patient satisfaction after surgery and during the follow-up period. Satisfaction is measured at four different levels: 1 (better) to 4 (worst) | At 1-6, 12 and 24 months postoperative |
| Cornebarrieu |
| 31700 |
| France |
| CHRU Tours, Hôpital de Bretonneau | Tours | 37044 | France |
| Hôpital Pitié-Salpêtrière AP-HP | Paris | Île-de-France Region | 75651 | France |
| Hagg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. doi: 10.1007/s00586-002-0464-0. Epub 2002 Oct 24. |
| 18805059 | Background | Glassman SD, Carreon LY, Djurasovic M, Dimar JR, Johnson JR, Puno RM, Campbell MJ. Lumbar fusion outcomes stratified by specific diagnostic indication. Spine J. 2009 Jan-Feb;9(1):13-21. doi: 10.1016/j.spinee.2008.08.011. Epub 2008 Sep 19. |
| 24206036 | Background | Fairbank JC. Why are there different versions of the Oswestry Disability Index? J Neurosurg Spine. 2014 Jan;20(1):83-6. doi: 10.3171/2013.9.SPINE13344. Epub 2013 Nov 8. |
| 11074683 | Background | Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017. |
| 23622053 | Background | Johnsen LG, Hellum C, Nygaard OP, Storheim K, Brox JI, Rossvoll I, Leivseth G, Grotle M. Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease. BMC Musculoskelet Disord. 2013 Apr 26;14:148. doi: 10.1186/1471-2474-14-148. |
| 23590789 | Background | Gum JL, Carreon LY, Stimac JD, Glassman SD. Predictors of Oswestry Disability Index worsening after lumbar fusion. Orthopedics. 2013 Apr;36(4):e478-83. doi: 10.3928/01477447-20130327-26. |
| 24980580 | Background | Ghogawala Z, Whitmore RG, Watters WC 3rd, Sharan A, Mummaneni PV, Dailey AT, Choudhri TF, Eck JC, Groff MW, Wang JC, Resnick DK, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 3: assessment of economic outcome. J Neurosurg Spine. 2014 Jul;21(1):14-22. doi: 10.3171/2014.4.SPINE14259. |
| 9817135 | Background | Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7. |
| FG002 | PASS Tulip | Correspond to all subjects implanted with the PASS Tulip |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PASS DEGEN | Correspond to all subjects implanted with the PASS DEGEN |
| BG001 | PASS LP | Correspond to all subjects implanted with the PASS LP |
| BG002 | PASS Tulip | Correspond to all subjects implanted with the PASS Tulip |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | weighted mean | Mean | Standard Deviation | Years |
| |||||||||
| Sex: Female, Male | weighted mean | Count of Participants | Participants |
| ||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participant Who Achieved Their Fusion at 24 Months | The primary endpoint is the fusion status of each patient at the 24-month visit postoperative. This fusion assessment will be done through the analysis of the standard of care imaging (CT-scan, X-rays, and/or MRI) by the investigator and through the clinical examination of the patient by the investigator. | Difference between number of participants is due to some missing data. | Posted | Count of Participants | Participants | At 24months |
|
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| Secondary | Evolution of the Pain (VAS) | Change of leg and back pain score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 10 (worst) | Difference between number of participants is due to some missing data. | Posted | Mean | Standard Deviation | units on a scale | Preoperative, and 1-6, 12 and 24 months postoperative |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Quality of Life With ODI | Change of non-validated ODI score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 50 (worst) | Difference between number of participants is due to some missing data. | Posted | Mean | Standard Deviation | ODI score | Preoperative, and 1-6, 12 and 24 months postoperative |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Quality of Life With SF-12 | Change of non-validated SF-12 score from the preoperative visit to all available postoperative timepoints: from to 0 (better) to 5 (worst) by question, then questions are combined following the SF12 provider recommendation. The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS and MCS can be between O and 100. | Difference between number of participants is due to some missing data. | Posted | Mean | Standard Deviation | units on a scale | Preoperative, and 1-6, 12 and 24 months postoperative |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Surgeons'Satisfaction With These Implants and Instruments | Surgeons will be requested to complete questions about device/surgery satisfaction. | Difference between number of participants is due to some missing data. | Posted | Count of Participants | Participants | During the surgery and until the 24months postoperative visit |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Fusion Status at the 1/6 Month and 12-month Visit | The primary objective is defined as the ability of the implant to promote the stabilization | Difference between number of participants is due to some missing data. | Posted | Count of Participants | Participants | At the 1-6, and 12 months postoperative |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Patient Satisfaction at All Available Postoperative Timepoints | Patient satisfaction is used to evaluate patient satisfaction after surgery and during the follow-up period. Satisfaction is measured at four different levels: 1 (better) to 4 (worst) | Difference between number of participants is due to some missing data. | Posted | Count of Participants | Participants | At 1-6, 12 and 24 months postoperative |
|
|
From enrollment up to 24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PASS DEGEN | Correspond to all subjects implanted with the PASS DEGEN | 0 | 23 | 4 | 23 | 5 | 23 |
| EG001 | PASS LP | Correspond to all subjects implanted with the PASS LP | 1 | 29 | 5 | 29 | 0 | 29 |
| EG002 | PASS Tulip | Correspond to all subjects implanted with the PASS Tulip | 0 | 25 | 7 | 25 | 0 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal Ischemia | Gastrointestinal disorders | Systematic Assessment |
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| Intervertebral discitis | Infections and infestations | Systematic Assessment |
| ||
| Postoperative Wound infections | Infections and infestations | Systematic Assessment |
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| Adjacent Segment Degeneration | Injury, poisoning and procedural complications | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pseudarthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sacroiliac joint dysfunction | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Breast cancer metastatic | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Carpal tunnel Syndrome | Nervous system disorders | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
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| Device loosening | Product Issues | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dural Tear | Nervous system disorders | Systematic Assessment |
|
The SF12 is a non validated revision.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carole Bergougnoux | Medtronic - Medicrea | +33472018787 | dl.affairescliniques@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2024 | Apr 10, 2026 | SAP_001.pdf |
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| satisfied |
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| Partly Satisfied |
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| Not satisfactory |
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| did not improve as much as I had hoped but I would undergo the same operation for the same results |
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| Surgery helped but I would not undergo the same operation for the same outcome. |
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| I am the same or worse as compared to before the surgery. |
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| did not improve as much as I had hoped but I would undergo the same operation for the same results |
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| Surgery helped but I would not undergo the same operation for the same outcome. |
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| I am the same or worse as compared to before the surgery. |
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