Recruiting

OPS

Sponsor:

Corin

Code:

NCT04319952

Conditions

Primary Total Hip Arthroplasty

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Primary Total Hip Replacement with Metafix™ femoral stem and Trinity™ acetabular cup or TriFit-CF™/TriFit-TS™ femoral stem and Trinity™ acetabular cup implanted by a single surgeon.

Study Details

Brief summary:

A prospective, non-randomized, single-center clinical study to determine the accuracy of a patient-specific instrument (OPS™) for delivering a planned femoral component anteversion and neck resection using a Direct Anterior Approach (DAA) in Total Hip Arthroplasy.

Conditions

Primary Total Hip Arthroplasty

Study ID

NCT04319952

Start date

Jan 13, 2020

Status verified date

Aug, 2021

Completion date

Apr, 2023

Anticipated

Primary completion date

Jan, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients who understand the conditions of the study and are willing to return to the clinical site at 2 weeks postoperatively.
  • Patients of either gender who are between 21-85 years (inclusive) at the time of consent.
  • Patients with a diagnosis of osteoarthritis (including post-traumatic osteoarthritis), rheumatoid arthritis or avascular necrosis and are considered by the Investigator to be clinically and medically suitable to undergo a primary total hip replacement.
  • Patients who meet the indications and none of the contraindications listed in the Instructions for Use (IFU) supplied by the manufacturer for the femoral stem and acetabular cup to be implanted.
  • Patients who meet the indications and none of the contraindications listed in the Instructions for Use (IFU) supplied by the manufacturer for OPS™ Femoral Plan and OPS™ Femoral Patient Specific Instruments.

Exclusion Criteria:

  • Patients who are unable to provide informed consent.
  • Patients who are unable to comply with all the required study procedures.
  • Patients who are currently involved in any personal injury litigation, medical-legal or worker's compensations claims.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Primary Total Hip Replacement with Metafix™ femoral stem and Trinity™ acetabular cup or TriFit-CF™/TriFit-TS™ femoral stem and Trinity™ acetabular cup implanted by a single surgeon.

The participant will undergo surgery using the hip prostheses and direct anterior surgical approach used by their surgeon-investigator. A patient-specific femoral guide, generated by the OPS™ Plan preoperatively, will be used during the surgical step of the femoral neck resection. These are not study specific procedures as the OPS™ Plan is already in use by the surgeon-investigator in their standard of care practice.

Primary outcome measure

  • Accuracy of the final osteotomy level compared to the selected OPS™ Plan [ Time Frame: 2 weeks post-op (1 - 4 weeks post-op window) ]

Central Contacts and Locations

Central contacts

Kassy Dunbar

214-385-1431kdunbar@exlor.com

Locations

Texas Orthopaedic Associates

Recruiting

Dallas, Texas, United States, 75225

Contacts

Kassy Dunbar

214-385-1431kdunbar@exlor.com

Principal Investigator:

Donald W Hohman, MD

Texas Orthopaedic Associates

Recruiting

Plano, Texas, United States, 75093

Contacts

Kassy Dunbar

214-385-1431kdunbar@exlor.com

Principal Investigator:

Donald W Hohman, MD

More Information

Sponsor

Corin

Last update posted

Aug 24, 2021

Last verified

Aug, 2021

Keywords

  • femoral neck resection
  • offset
  • leg length
  • femoral anteversion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corin on 2021-08-24.