Recruiting

Observational Study

Sponsor:

Signature Orthopaedics

Code:

NCT04123600

Conditions

Hip Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Origin Stem and Logical Cup

Study Details

Brief summary:

The aim of the study is to monitor the performance of the Signature Orthopaedics Origin Stem and Logical Acetabular Cup as part of post-market vigilance and continuous improvement efforts.

Conditions

Hip Disease

Study ID

NCT04123600

Start date

Nov 19, 2019

Status verified date

Sep, 2021

Completion date

Nov 19, 2023

Anticipated

Primary completion date

Nov 19, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
  • patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient
  • male and non-pregnant female patients aged 18-75
  • patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up

Exclusion Criteria:

  • patient has active infection or sepsis (treated or untreated)
  • patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
  • patient is female of child-bearing age and not taking contraceptive precautions
  • patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
  • patient has inflammatory joint disease (e.g. rheumatoid arthritis)
  • patient has known moderate to severe renal deficiency
  • patient has a known or suspected metal sensitivity
  • patient is immuno-suppressed with diseases such as AIDS or is receiving high dose of corticosteroids
  • patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
  • patient is severely overweight with a BMI>40.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Origin Stem and Logical Cup

The Origin Stem is a straight, tapered, HA coated cementless femoral stem, and the Logical Cup is a porous coated acetabular cup mated with a cross-linked polyethylene liner. The components are used as part of a total joint replacement prosthesis.

Primary outcome measure

  • Stem and Cup Survival Rate [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Melody C Labrune, MS

+61 02 9428 5181melody.labrune@signatureortho.com.au

Declan Brazil, PhD

+61 02 9428 5181declan@signatureortho.com.au

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Laura Stiegel

STIEGEL@ccf.org

Principal Investigator:

Atul Kamath, MD

More Information

Sponsor

Signature Orthopaedics

Last update posted

Sep 22, 2021

Last verified

Sep, 2021

Keywords

  • Hip Replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Signature Orthopaedics on 2021-09-22.