Recruiting

Observational Study

Sponsor:

Exactech

Code:

NCT05849961

Conditions

Hip Arthroplasty, Total

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exactech Hip Systems

Study Details

Brief summary:

A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems

Conditions

Hip Arthroplasty, Total

Study ID

NCT05849961

Start date

Oct 13, 2023

Status verified date

Jun, 2024

Completion date

Dec 31, 2036

Anticipated

Primary completion date

Jul 31, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2946 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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).

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.

Interventions

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.

Primary outcome measure

  • Harris Hip Score [ Time Frame: Preoperative ]
  • Harris Hip Score [ Time Frame: 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 [ Time Frame: Annually up to 10 years; per standard of care ]
  • Oxford Hip Score [ Time Frame: Preoperative ]
  • Oxford Hip Score [ Time Frame: 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 [ Time Frame: Annually up to 10 years; per standard of care ]

Central Contacts and Locations

Locations

Tulsa Bone & Joint Associates

Recruiting

Tulsa, Oklahoma, United States, 74146

Contacts

Principal Investigator:

Scott Dunitz, MD

More Information

Sponsor

Exactech

Last update posted

Jun 18, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Exactech on 2024-06-18.