NCT04319952

OPS™ With Direct Anterior Approach (DAA)

A Study to Demonstrate the Accuracy of the Femoral Neck Resection Compared to the Selected OPS™ Plan Using the Direct Anterior Approach (DAA)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Corin · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Total Hip Replacement (THR) is the gold standard for treatment of severe arthritis of the hip as it relieves pain, restores function of the joint, and improves quality of life for patients. The restoration of hip mechanics can be influenced by the selected femoral stem design and also by choices made by the surgeon during the surgical implantation. The combination of femoral neck resection level and angle are key factors, particularly in cementless hip arthroplasty, in determining post-operative leg length and femoral anteversion. Historically, an estimation of prosthesis sizing and positioning has been made via a process of manual or digital templating either pre or intraoperatively using images of the implants positioned over the standard AP and lateral view hip x-rays taken in advance of surgery with generic instruments used during the surgery to execute the femoral head resection at the planned level. This process has a number of limitations. The OPS™ system utilizes detailed pre-operative imaging including a CT scan to generate a plan for the femoral neck resection level and angulation based on the anatomy of the individual patient. Following validation of this plan by the operating clinician, a patient specific femoral guide instrument is generated to help facilitate the reliable delivery of the planned resection intraoperatively. The purpose of this study will be to evaluate the use of the patient-specific femoral instrument in the hands of one surgeon using a protocol-specific choice of prosthesis combinations and one surgical approach. A total number of 100 subjects will be enrolled. Participants in this study will return for a single post-operative visit at 6 weeks to have x-rays taken and to enable any postoperative study hip-related complications recorded. Once this has been completed, participants will be routinely followed-up by their Orthopedic surgeon as required in accordance with the standard clinical practice.

Conditions

• Primary Total Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2020-01-13
• Primary completion: 2023-01-01
• Completion: 2023-04-01
• First posted: 2020-03-24
• Last updated: 2021-08-24

Locations

2 sites across 1 country: United States