OPS™ With Direct Anterior Approach (DAA)

NCT04319952 | Unknown

• 1 other identifier: CSP2019-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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

Keywords

femoral neck resection; offset; leg length; femoral anteversion

Outcome Measures

Primary Outcomes (1)

• Accuracy of the final osteotomy level compared to the selected OPS™ Plan

  Accuracy of the final osteotomy level compared to the selected OPS™ Plan (+ or - 3 mm). Two standard of care postoperative x-rays taken at 2 weeks will be used to evaluate the positioning of the total hip prosthesis from the resultant level of resection of the femoral neck. This parameter will be measured in mm.

  2 weeks post-op (1 - 4 weeks post-op window)

Secondary Outcomes (5)

• Comparison of the femoral stem size implanted compared to the selected OPS™ Plan

  Immediate postoperative

• Comparison of the acetabular cup size implanted compared to the OPS™Plan

  Immediate postoperative

• Comparison of the femoral head size implanted compared to the selected OPS™ Plan

  Immediate postoperative

• Measurement of any change in leg length / femoral head height compared to the preoperative OPS™ Plan

  2 weeks post-op (1 - 4 weeks post-op window)

• Comparison of the acetabular cup orientation to the selected OPS™ Plan

  2 weeks post-op (1 - 4 weeks post-op window)

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. DEVICE

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.

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from the surgeon's clinic. Those who meed the inclusion/exclusion criteria will be invited to enroll into the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corin: lead

Study Sites (2)

Texas Orthopaedic Associates

Dallas, Texas, 75225, United States

RECRUITING

Texas Orthopaedic Associates

Plano, Texas, 75093, United States

RECRUITING

Study Officials

• Donald W Hohman, MD

  Surgical Education & Research LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassy Dunbar

CONTACT

214-385-1431; kdunbar@exlor.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: March 24, 2020
• Study Start: January 13, 2020
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

US (2)