Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)

June 17, 2024 updated by: Exactech

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

Study Overview

Status

Status

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

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

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 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 (Estimated)

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.
2946

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Tulsa Bone & Joint Associates
        • Contact:
        • Principal Investigator:
          • Scott Dunitz, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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.
  • 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

Exclusion Criteria:

  • 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)

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

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.
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.
Device: Exactech Hip Systems
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.
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).
Device: Exactech Hip Systems
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.
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.
Device: Exactech Hip Systems
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.

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
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.
Preoperative
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.
4-6 week Post-op; per 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.
3-6 month Post-op; per 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.
Annually up to 10 years; per 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.
Preoperative
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.
4-6 week Post-op; per 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.
3-6 month Post-op; per 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.
Annually up to 10 years; per standard of care

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.
Exactech

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.
October 13, 2023

Primary Completion (Estimated)

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.
July 31, 2036

Study Completion (Estimated)

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.
December 31, 2036

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).
April 14, 2023

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.
April 28, 2023

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 9, 2023

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.
June 18, 2024

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.
June 17, 2024

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.
June 1, 2024

More Information

Terms related to this study

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.
  • TM-2023-017318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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