Primary Total Hip ArthroplastyNCT04319952
OPS™ With Direct Anterior Approach (DAA)
An observational study of Primary Total Hip Arthroplasty, run by Corin at 2 sites in United States.
Trial 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. 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 Metafix™ femoral stem and Trinity™ acetabular cup or TriFit-CF™/TriFit-TS™ femoral stem and Trinity™ acetabular cup implanted by a single surgeon.
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2020to Apr 2023
- 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 surgeon's clinic. Those who meed the inclusion/exclusion criteria will be invited to enroll 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 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Texas Orthopaedic Associates
Dallas, Texas, 75225
Kassy Dunbar, 214-385-1431, kdunbar@exlor.com
Donald W Hohman, MD
- Recruiting
Texas Orthopaedic Associates
Plano, Texas, 75093
Kassy Dunbar, 214-385-1431, kdunbar@exlor.com
Donald W Hohman, MD
About this study
Official title: A Study to Demonstrate the Accuracy of the Femoral Neck Resection Compared to the Selected OPS™ Plan Using the Direct Anterior Approach (DAA)
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.
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 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
- Being tested
- 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.
- Keywords
- femoral neck resection, offset, leg length, 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 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.
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
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.
Measured: 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
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 one selected by the OPS™ Plan. This parameter will be measured in units.
Measured: Immediate postoperative
Comparison of the acetabular cup size implanted compared to the OPS™Plan
Comparison of the acetabular cup size implanted compared to the OPS™Plan preoperatively. The acetabular cup size used during the operation will be compared to the one selected 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
Comparison of the femoral head size implanted compared to the selected 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
Measurement of any change in leg length / femoral head height compared to the preoperative OPS™ Plan (+ or - 5 mm). The postoperative leg length / femoral head height will be measured in mm and compared to the preoperative value.
Measured: 2 weeks post-op (1 - 4 weeks post-op window)
Comparison of the acetabular cup orientation to the selected OPS™ Plan
Comparison of the acetabular cup orientation to the selected OPS™ Plan. The planned vs achieved acetabular cup orientation will be measured using 2D/3D registration software, in degrees.
Measured: 2 weeks post-op (1 - 4 weeks post-op window)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start13 Jan 2020
- Primary completionJan 2023 (estimated)
- Study completionApr 2023 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald W Hohman, MD, Principal investigator, Surgical Education & Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319952
- Sponsor's protocol ID
- CSP2019-02
- Status last verified
- Aug 2021
- First submitted
- 22 Mar 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Demonstrate the Accuracy of the Femoral Neck Resection Compared to the Selected OPS™ Plan Using the Direct Anterior Approach (DAA)
- ClinicalTrials.gov ID
- NCT04319952
- Acronym / sponsor ID
- CSP2019-02
- Conditions
- Primary Total Hip Arthroplasty
- Keywords
- femoral neck resection, offset, leg length, femoral anteversion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 24 Mar 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 surgeon's clinic. Those who meed the inclusion/exclusion criteria will be invited to enroll 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 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.
Key exclusion criteria (3 listed)
- 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.
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 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. | Device | – |
Primary outcome
Accuracy of the final osteotomy level compared to the selected OPS™ Plan
Time frame: 2 weeks post-op (1 - 4 weeks post-op window)
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.
5 secondary outcomes
Comparison of the femoral stem size implanted compared to the selected OPS™ Plan
Time frame: Immediate postoperative
Comparison of the acetabular cup size implanted compared to the OPS™Plan
Time frame: Immediate postoperative
Comparison of the femoral head size implanted compared to the selected OPS™ Plan
Time frame: Immediate postoperative
Measurement of any change in leg length / femoral head height compared to the preoperative OPS™ Plan
Time frame: 2 weeks post-op (1 - 4 weeks post-op window)
Comparison of the acetabular cup orientation to the selected OPS™ Plan
Time frame: 2 weeks post-op (1 - 4 weeks post-op window)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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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.
Donald W Hohman, MD principal investigator
Surgical Education & Research LLC
2 sites 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 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kassy Dunbar (214-385-1431, kdunbar@exlor.com), or a site near the patient. 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 (time frame: 2 weeks post-op (1 - 4 weeks post-op window)). 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 Aug 2021.