Hip Arthroplasty, TotalNCT05849961
Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)
An observational study of Hip Arthroplasty, Total, run by Exactech at 1 site in United States.
Trial summary
A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthroplasty, Total
- What is being tested?
- Exactech Hip Systems
- Type of treatment
- Medical device
- How many people
- 2,946 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2023to 31 Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients must qualify for surgery per indications and contraindications and meet all the inclusion criteria and none of the exclusion criteria. The decision to offer a patient enrollment in this study is left to the surgeon's discretion.
Who may be able to join
- Cohort 1:
- Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
- Skeletally mature (18 years of age or older).
- The subject is willing and able to provide written informed consent for participation in the study.
- Subject is to receive an Exactech Hip System THA for any approved indication for use.
- The hip replacement will be performed by the investigator or a surgeon sub- investigator.
Show all 49Show fewer
- The devices will be used according to the approved indications.
- Cohort 2:
- Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will be collected from the subject's medical record for the time-period prior to enrollment in the study containing data pertaining to the preoperative time period and index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time- period (prospectively).
- Skeletally mature (18 years of age or older).
- The subject is willing and able to provide written informed consent for participation in the study.
- Subject received an Exactech Hip System THA for any approved indication for use.
- The hip replacement was performed by the investigator or a surgeon sub-investigator.
- The devices are/were used according to the approved indications.
- Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre- operative, operative, and applicable postoperative data available in the subject's medical records, related to the Exactech Hip System prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission:
- Pre-Operative:
- Demographic Data
- Gender
- Age at surgery
- Height/Weight
- Indication for surgery
- Prior Injuries/Surgeries on index hip
- Comorbidities
- Operative:
- Date of Surgery
- Type of Surgery (Primary / Revision)
- All component product information, including catalogue reference numbers.
- Adverse Event Information, if applicable
- Cohort 3:
- Note: No prospective data may be collected from a subject if they are enrolled under this cohort unless the subject is willing and able to provide written informed consent for participation in the study, in which case they should be part of Cohort 2.
- Skeletally mature (18 years of age or older).
- The subject is willing and able to provide written informed consent for participation in the study.
- Subject received an Exactech Hip System THA for any approved indication for use.
- The hip replacement was performed by the investigator or a surgeon sub-investigator.
- The devices are/were used according to the approved indications.
- Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre- operative, operative, and applicable postoperative data available in the subject's medical records, related to the Exactech Hip System prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission:
- Pre-Operative:
- Demographic Data
- Gender
- Age at surgery
- Height/Weight
- Indication for surgery
- Prior Injuries/Surgeries on index hip
- Comorbidities
- Operative:
- Date of Surgery
- Type of Surgery (Primary / Revision)
- All component product information, including catalogue reference numbers.
- Adverse Event Information, if applicable
Who cannot join
- Patient was <18 years of age at time of surgery
- Patient does not meet the indicated population for use criteria for this device.
- Patient is pregnant
- Patient is a prisoner
- Patient has a physical or mental condition that would invalidate the results
- Patient is contraindicated for the surgery (e.g., metal allergy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tulsa Bone & Joint Associates
Tulsa, Oklahoma, 74146
Faye Biggs, 918-392-1400, f.biggs@tbja.org
Scott Dunitz, MD
About this study
Official title: TM-2023-017318 Exactech Hip Systems PMCF: A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
Read the detailed description
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive an Exactech Hip System for total hip arthroplasty (THA) prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
- Conditions
- Hip Arthroplasty, Total
- Being tested
- Exactech Hip Systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exactech Hip SystemsDevice
The Exactech Hip System comprises a fixed-bearing hip joint prostheses used in treating human hip joint diseases as part of THA. These prostheses include a combination of the components and are available in a range of sizes to accommodate varying anatomical requirements.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Subjects | Enrolled in the study pre-surgery. Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study. Receives: Device: Exactech Hip Systems | |
| Retrospective to Prospective | Subjects enrolled in the study post- surgery then continue to participate in the study prospectively. Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively). Receives: Device: Exactech Hip Systems | |
| Retrospective Only Subjects | Subjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Patient's clinical record includes a signed HIPAA waiver allowing for the use of clinical record data for the purpose of clinical research outside of the operating institution. Receives: Device: Exactech Hip Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Measured: Preoperative
Harris Hip Score
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Measured: 4-6 week Post-op; per standard of care
Harris Hip Score
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Measured: 3-6 month Post-op; per standard of care
Harris Hip Score
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Measured: Annually up to 10 years; per standard of care
Oxford Hip Score
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Measured: Preoperative
Oxford Hip Score
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Measured: 4-6 week Post-op; per standard of care
Oxford Hip Score
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Measured: 3-6 month Post-op; per standard of care
Oxford Hip Score
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Measured: Annually up to 10 years; per standard of care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start13 Oct 2023
- Primary completion31 Jul 2036 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by ExactechThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 2,946 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849961
- Sponsor's protocol ID
- TM-2023-017318
- Status last verified
- Jun 2024
- First submitted
- 14 Apr 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TM-2023-017318 Exactech Hip Systems PMCF: A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
- ClinicalTrials.gov ID
- NCT05849961
- Acronym / sponsor ID
- TM-2023-017318
- Conditions
- Hip Arthroplasty, Total
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,946 participants (estimated)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 31 Jul 2036 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 9 May 2023 (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 Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
Detailed description
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive an Exactech Hip System for total hip arthroplasty (THA) prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective Subjects | – | Device: Exactech Hip SystemsEnrolled in the study pre-surgery. Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study. |
| Retrospective to Prospective | – | Device: Exactech Hip SystemsSubjects enrolled in the study post- surgery then continue to participate in the study prospectively. Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively). |
| Retrospective Only Subjects | – | Device: Exactech Hip SystemsSubjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Patient's clinical record includes a signed HIPAA waiver allowing for the use of clinical record data for the purpose of clinical research outside of the operating institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must qualify for surgery per indications and contraindications and meet all the inclusion criteria and none of the exclusion criteria. The decision to offer a patient enrollment in this study is left to the surgeon's discretion.
Key inclusion criteria (49 listed)
- Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
- Skeletally mature (18 years of age or older).
- The subject is willing and able to provide written informed consent for participation in the study.
- Subject is to receive an Exactech Hip System THA for any approved indication for use.
- The hip replacement will be performed by the investigator or a surgeon sub- investigator.
Key exclusion criteria (6 listed)
- Patient was <18 years of age at time of surgery
- Patient does not meet the indicated population for use criteria for this device.
- Patient is pregnant
- Patient is a prisoner
- Patient has a physical or mental condition that would invalidate the results
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 |
|---|---|---|
| Exactech Hip SystemsThe Exactech Hip System comprises a fixed-bearing hip joint prostheses used in treating human hip joint diseases as part of THA. These prostheses include a combination of the components and are available in a range of sizes to accommodate varying anatomical requirements. | Device | Prospective Subjects, Retrospective Only Subjects, Retrospective to Prospective |
Primary outcome
Harris Hip Score
Time frame: Preoperative
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Harris Hip Score
Time frame: 4-6 week Post-op; per standard of care
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Harris Hip Score
Time frame: 3-6 month Post-op; per standard of care
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Harris Hip Score
Time frame: Annually up to 10 years; per standard of care
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Oxford Hip Score
Time frame: Preoperative
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Oxford Hip Score
Time frame: 4-6 week Post-op; per standard of care
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Oxford Hip Score
Time frame: 3-6 month Post-op; per standard of care
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Oxford Hip Score
Time frame: Annually up to 10 years; per standard of care
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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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.
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 Hip Arthroplasty, Total, run by Exactech 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 49 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pearl Harris (352-377-1140, pearl.harris@exac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (time frame: Preoperative). The study lists 8 primary outcomes in all. 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 18 Jun 2024.