Accuracy of OPS™ Femoral Neck Resection Study

September 22, 2021 updated by: Corin

A Study to Demonstrate the Accuracy of Femoral Neck Resection Compared to the Pre-operatively Selected OPS™ Plan in Total Hip Arthroplasty.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 two surgeons using different prosthesis combinations and surgical approaches. A total number of 40 participants 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 post-operative study hip related complications to be recorded. Once this has been completed, participants will be routinely followed-up by their orthopaedic surgeon as required in accordance with standard clinical practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Joint Replacement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  1. Patients who understand the conditions of the study and are willing to return to the clinical site at 6 weeks post-operatively.
  2. Patients of either gender who are between 21-85 years inclusive.
  3. 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
  4. 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.
  5. 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:

  1. Patients who are unable to provide informed consent.
  2. Patients who are unable to comply with all the required study procedures.
  3. 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.
  4. Patients who are currently involved in any personal injury litigation, medical-legal or worker's compensations claims.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy of the final osteotomy level compared to the selected OPS™ plan preopertively.
Time Frame: 6 weeks post-op (+/- 2 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of the femoral stem size implanted compared to the selected OPS™ Plan preoperatively (± 1 size)
Time Frame: Immediate postoperative
The femoral stem size used during the operation will be compared to the selected one by the OPS™ Plan. This parameter will be measured in units.
Immediate postoperative
Comparison of the acetabular cup size implanted compared to the selected OPS™ Plan preoperatively.
Time Frame: Immediate postoperative
The acetabular cup size used during the operation will be compared to the selected one by the OPS™ Plan. This parameter will be measured in mm.
Immediate postoperative
Comparison of the femoral head size implanted compared to the selected OPS™ Plan preoperatively.
Time Frame: Immediate postoperative
The femoral head size used during the operation will be compared to the selected one by the OPS™ Plan. This parameter will be measured in mm.
Immediate postoperative
Measurement of any change in Leg length/ femoral head height compared to the preoperative OPS™ Plan (± 5mm).
Time Frame: 6 weeks post-op (+/- 2 weeks)
The postoperative Leg length / femoral head height will be measured in mm and compared to the preoperative value.
6 weeks post-op (+/- 2 weeks)
Comparison of the acetabular cup orientation to the selected OPS™ Plan.
Time Frame: 6 weeks post-op (+/- 2 weeks)
The planned versus achieved acetabular cup orientation will be measured using 2D/3D registration software, in degrees.
6 weeks post-op (+/- 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSP2018-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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