Primary Total Hip ArthroplastyNCT03956381
Accuracy of OPS™ Femoral Neck Resection Study
An observational study of Primary Total Hip Arthroplasty, run by Corin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Primary Total Hip Arthroplasty
- What is being tested?
- Primary Total Hip Replacement with Trinity cup and TriFit TS stem via posterolateral surgical approach. and Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approach
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Total Hip Arthroplasty
- Being tested
- Primary Total Hip Replacement with Trinity cup and TriFit TS stem via posterolateral surgical approach., Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approach
- Keywords
- Femoral neck resection, offset, leg lenght, femoral anteversion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approachDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Immediate postoperative
Comparison of the acetabular cup size implanted compared to the selected OPS™ Plan preoperatively.
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.
Measured: Immediate postoperative
Comparison of the femoral head size implanted compared to the selected OPS™ Plan preoperatively.
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.
Measured: Immediate postoperative
Measurement of any change in Leg length/ femoral head height compared to the preoperative OPS™ Plan (± 5mm).
The postoperative Leg length / femoral head height will be measured in mm and compared to the preoperative value.
Measured: 6 weeks post-op (+/- 2 weeks)
Comparison of the acetabular cup orientation to the selected OPS™ Plan.
The planned versus achieved acetabular cup orientation will be measured using 2D/3D registration software, in degrees.
Measured: 6 weeks post-op (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start24 Apr 2019
- Primary completion15 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Jennings, MD, Principal investigator, Colorado Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956381
- Sponsor's protocol ID
- CSP2018-03
- Status last verified
- Sep 2021
- First submitted
- 8 May 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Demonstrate the Accuracy of Femoral Neck Resection Compared to the Pre-operatively Selected OPS™ Plan in Total Hip Arthroplasty.
- ClinicalTrials.gov ID
- NCT03956381
- Acronym / sponsor ID
- CSP2018-03
- Conditions
- Primary Total Hip Arthroplasty
- Keywords
- Femoral neck resection, offset, leg lenght, femoral anteversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THR with OPS system-TriFit TS/Trinity combination | – | Device: Primary Total Hip Replacement with Trinity cup and TriFit TS stem via posterolateral surgical approach.Hip prosthesis combination: TriFit TS stem/ Trinity cup implanted by Surgeon 1 via a posterolateral approach according to their standard of practice. |
| THR with OPS system-MetaFix/Trinity combination | – | Device: Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approachHip prosthesis combination: MetaFix stem/ Trinity cup implanted by Surgeon 2 via a direct anterior approach according to their standard of practice. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | THR with OPS system-TriFit TS/Trinity combination |
| Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approachThe 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. | Device | THR with OPS system-MetaFix/Trinity combination |
Primary outcome
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.
5 secondary outcomes
Comparison of the femoral stem size implanted compared to the selected OPS™ Plan preoperatively (± 1 size)
Time frame: Immediate postoperative
Comparison of the acetabular cup size implanted compared to the selected OPS™ Plan preoperatively.
Time frame: Immediate postoperative
Comparison of the femoral head size implanted compared to the selected OPS™ Plan preoperatively.
Time frame: 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)
Comparison of the acetabular cup orientation to the selected OPS™ Plan.
Time frame: 6 weeks post-op (+/- 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Optimized Positioning System (OPS™)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Jennings, MD principal investigator
Colorado Joint Replacement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Total Hip Arthroplasty, run by Corin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the final osteotomy level compared to the selected OPS™ plan preopertively. (time frame: 6 weeks post-op (+/- 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.