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Recruiting

NCT Number: NCT06487936

Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion

This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.

Recruiting

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Key information

Conditions

Sacroiliac Joint Dysfunction Sacroiliac; Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Orthopedic Center

Port Charlotte, Florida, 33948, United States

Location status: Recruiting

Location contact

Lee James, DO

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 year or older
  • Confirmed Implant of the Transloc 3D Fusion System
  • Did not have Transloc device removed or another manufacturer device implanted post Transloc
  • Does not have other manufacturer's titanium or metal implant
  • Patient may be included with prior allograft implant
  • Willing to participate and give written consent
  • Must have or planned CT post ≥1 year per standard of care

Exclusion criteria

  • Patient is younger than 18 years
  • Patient is unable to sign the Informed Consent
  • Implant of other manufacturer's titanium or alternative metal implant
  • Revision with another manufacturer's implant
  • Fracture or unresolved trauma of implant side after implantation of TransLoc
  • Patient unwilling to participate in Patient Satisfaction Survey
  • Patient has not returned for Standard of Care follow-up

Treatment and study plan

TransLoc 3D SI Joint Fusion System

Device

Satisfaction survey will be administered to collect real world evidence on patients that previously received the TransLoc 3D System commercially.

Primary outcomes

  1. Patient Satisfaction Survey

    Time frame: Prospective 12 to 18 months post surgery

    Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint

Secondary outcomes

  1. Visual Analogue Scale (VAS) of pain

    Time frame: Baseline up to 1 year post surgery

    Retrospective analysis of VAS pre and post surgery, if available

  2. Oswestry Disability Index (ODI)

    Time frame: Baseline up to 1 year post surgery

    Retrospective analysis of ODI pre and post surgery, if available

  3. SAEs

    Time frame: Time of surgery up to 90 days post surgery

    Retrospective capture of Serious Adverse Events (SAEs) from the time of SI Fusion up to 90 days post operatively that required re-operation or in-patient hospitalization.

  4. CT Scan Second Read (Radiological Overread)

    Time frame: 12 to 18 months post fusion surgery

    CT scan for placement and fusion

Study contacts

Contact information is provided by the study sponsor or research team.

Bob Compton

CONTACT

[email protected]

Carley Wiegner

CONTACT

[email protected]

888-743-8736

Sponsors and collaborators

Lead sponsor

CornerLoc

Industry

Registry information

Official study title

A Multi-Center, Real World Prospective/Retrospective Registry to Evaluate Patient Satisfaction With the TransLoc 3D SI Joint Fusion System

Acronym: RELIEF

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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