Restor3D Outcomes Registry: Patient-specific Joint Implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The restor3d Outcomes Registry is a prospective, decentralized, longitudinal observational study enrolling adults who have received a restor3d patient-specific orthopedic implant across multiple joint cohorts (knee, hip, foot & ankle, shoulder). Participants complete electronic patient-reported outcomes before surgery and at defined intervals up to five years postoperatively, without in-person visits. The study uses a master protocol with joint-specific appendices to standardize data collection and aims to quantify changes in pain, function, quality of life, and satisfaction while establishing real-world benchmarks for these implants. Enrollment is limited to US-based patients receiving FDA-cleared or approved restor3d implants and who speak English to ensure accurate survey completion. Lead sponsor is Restor3D, with no collaborators and a single participating site in Durham, NC.

Why it matters

Who can join: the full rules

Master Protocol Inclusion Criteria:

* Age ≥ 18 years
* Prescribed an FDA-cleared or approved orthopedic implant manufactured by restor3d, Inc.

Master Protocol Exclusion Criteria:

* Patient is receiving an implant not manufactured by restor3d
* Patient is receiving a restor3d implant that is not FDA-cleared or approved
* Patient lives outside the United States
* Patient is receiving a restor3d implant that does not use a patient-specific plan, instrumentation or implant
* Patient is non-English-speaking (to ensure accurate comprehension and completion of the surveys)
* Patient is receiving a restor3d implant outside of the defined implant cohorts
* Patient does not provide informed consent

Where it's running

• Restor3D
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Kathryn Jackson
• Email: clinicalresearch@restor3d.com
• Phone: 984-248-0533

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.