Accuracy of OPS™ Femoral Neck Resection Study

NCT03956381 | Completed

• 1 other identifier: CSP2018-03
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the accuracy of the Optimized Positioning System (OPS™) planning and delivery tools using different types of surgical approaches.

Conditions

Primary Total Hip Arthroplasty

Keywords

Femoral neck resection, offset, leg lenght, femoral anteversion

Outcome Measures

Primary Outcomes (1)

• Accuracy of the final osteotomy level compared to the selected OPS™ plan preopertively.

  Accuracy of the final osteotomy level compared to the selected OPS™ plan (+ or - 3mm). Two standard of care post-operative x-rays taken at 6 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.

  6 weeks post-op (+/- 2 weeks)

Secondary Outcomes (5)

• Comparison of the femoral stem size implanted compared to the selected OPS™ Plan preoperatively (± 1 size)

  Immediate postoperative

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

  Immediate postoperative

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

  Immediate postoperative

• Measurement of any change in Leg length/ femoral head height compared to the preoperative OPS™ Plan (± 5mm).

  6 weeks post-op (+/- 2 weeks)

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

  6 weeks post-op (+/- 2 weeks)

Study Arms (2)

THR with OPS system-TriFit TS/Trinity combination

Hip prosthesis combination: TriFit TS stem/ Trinity cup implanted by Surgeon 1 via a posterolateral approach according to their standard of practice.

Device: Primary Total Hip Replacement with Trinity cup and TriFit TS stem via posterolateral surgical approach.

THR with OPS system-MetaFix/Trinity combination

Hip prosthesis combination: MetaFix stem/ Trinity cup implanted by Surgeon 2 via a direct anterior approach according to their standard of practice.

Device: Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approach

Interventions

Primary Total Hip Replacement with Trinity cup and TriFit TS stem via posterolateral surgical approach. DEVICE

The participant will undergo surgery using the hip prostheses and 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 femoral neck resection. These are not study specific procedures as the OPS™ system is already in use by the surgeon Investigator in their standard of practice.

THR with OPS system-TriFit TS/Trinity combination

Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approach DEVICE

The participant will undergo surgery using the hip prostheses and 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 femoral neck resection. These are not study specific procedures as the OPS™ system is already in use by the surgeon Investigator in their standard of practice.

THR with OPS system-MetaFix/Trinity combination

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 clinic registry at each of the investigational sites of those patients requiring a primary hip replacement. Those who meet the inclusion/exclusion criteria will be invited to enrol 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 6 weeks post-operatively.
• Patients of either gender who are between 21-85 years inclusive.
• Patients with a diagnosis of osteoarthritis, rheumatoid arthritis or osteonecrosis 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 whose insurance will not cover the cost of the pre-operative CT and functional x-ray imaging required for use of the OPS system.
• Patients who are currently involved in any personal injury litigation, medical-legal or worker's compensations claims.

Sponsors & Collaborators

• Corin: lead

Study Sites (1)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Related Links

• Optimized Positioning System (OPS™)

Study Officials

• Jason Jennings, MD

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 20, 2019
• Study Start: April 24, 2019
• Primary Completion: June 15, 2021
• Study Completion: July 31, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)