Stronger Together Global Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

2285 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2028-08-31

Brief Summary

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A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.

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Detailed Description

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To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.

Conditions

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Spinal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Implanted with SeaSpine spinal or orthobiologics product

Standard of Care Registry- Patients must have been implanted with at least one SeaSpine product

Spinal Surgery with SeaSpine product

Intervention Type DEVICE

Implanted with SeaSpine spinal or orthobiologic product

Interventions

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Spinal Surgery with SeaSpine product

Implanted with SeaSpine spinal or orthobiologic product

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have been treated with at least one SeaSpine product.
* Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative.
* Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care.
* Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits.

Exclusion Criteria

* Was not implanted with at least one SeaSpine product during operation
* Any other condition that the Investigator determines is unacceptable for enrollment into this registry

Eligible Sex

ALL

Accepts Healthy Volunteers

No