An interventional study of Dynesys Spinal System in Degenerative Spondylolisthesis and Pseudoarthrosis, sponsored by Zimmer Biomet. Terminated at 9 sites in United States. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Zimmer Biomet · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.
41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.
This study's enrollment of 153 is above the median of 22 across 25 interventional studies indexed under Pseudarthrosis.
Browse Pseudarthrosis studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will receive the Dynesys System and all patients will be compared to historical literature control. Dynesys Spinal System will be used for all subjects.
Device: Dynesys Spinal System
Dynesys Spinal System will be used for all subjects
Fusion Rates
Fusion was defined by meeting three criteria: * rotation \< 5° between motion segments on flexion-extension radiographs * translation \< 3 mm between motion segments on flexion-extension radiographs * presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control.
Time frame: 24 months post surgery date
| Milestone | Dynesys System |
|---|---|
| Started | 140 |
| Completed | 66 |
| Not completed | 74 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Physician decision | 1 |
| Withdrew: Determined not eligible by aeac | 1 |
| Withdrew: Missed visit | 2 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Explanted | 2 |
| Withdrew: Site closure | 4 |
| Withdrew: Death | 2 |
| Withdrew: Early termination of study | 52 |
Fusion was defined by meeting three criteria: * rotation \< 5° between motion segments on flexion-extension radiographs * translation \< 3 mm between motion segments on flexion-extension radiographs * presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control.
| Participants | Dynesys System |
|---|---|
| Proportion fused | 33 |
| Proportion not fused | 19 |
| Proportion with Partial Fusion | 5 |
| Proportion unable to assess | 4 |
Collected over Adverse events were collected from the time of surgery through the participants last visit; up to 48months.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dynesys System | 2/139 (1.4%) | 33/139 (23.7%) | 71/139 (51.1%) |
| Event | Dynesys System |
|---|---|
| RadiculitisNervous system disorders | 5/139 |
| Other- Adjacent level diseaseMusculoskeletal and connective tissue disorders | 4/139 |
| Other- Spinal stenosisMusculoskeletal and connective tissue disorders | 4/139 |
| Intracranial hemorrhageNervous system disorders | 2/139 |
| Myocardial infarctionCardiac disorders | 2/139 |
| Other- Total hip arthoroplastyMusculoskeletal and connective tissue disorders | 2/139 |
| AcidosisMetabolism and nutrition disorders | 1/139 |
| Allergic reactionImmune system disorders | 1/139 |
| AnemiaBlood and lymphatic system disorders | 1/139 |
| Coronary Artery DiseaseCardiac disorders | 1/139 |
| Event | Dynesys System |
|---|---|
| Back painMusculoskeletal and connective tissue disorders | 10/139 |
| Intraoperative neurological injuryInjury, poisoning and procedural complications | 5/139 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 5/139 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/139 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/139 |
| NeuralgiaNervous system disorders | 5/139 |
| ParesthesiaNervous system disorders | 4/139 |
| Other- Pain low backNervous system disorders | 4/139 |
| Buttock painMusculoskeletal and connective tissue disorders | 3/139 |
| RadiculitisNervous system disorders | 3/139 |
Baseline variables were summarized for all subjects who were eligible, enrolled in the study and underwent a surgical procedure where the Dynesys® Spinal System was implanted.
| Age, Continuous(years) | Dynesys System |
|---|---|
| Mean | 63.9 ± 9.9 |
| Sex: Female, Male(Participants) | Dynesys System |
|---|---|
| Female | 88 |
| Male | 51 |
| Race and Ethnicity Not Collected(Participants) | Dynesys System |
|---|
| Height(inches) | Dynesys System |
|---|---|
| Mean | 65.7 ± 3.7 |
| Weight(pounds) | Dynesys System |
|---|---|
| Mean | 184.6 ± 39.6 |
| BMI((kg/mg^2)) | Dynesys System |
|---|---|
| Mean | 30 ± 5.4 |
PDFs hosted by the registry, ClinicalTrials.gov.
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