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

Description

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

Conditions

Hip Arthroplasty, Total

Study Overview

Study Details

Study overview

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

TM-2023-017318 Exactech Hip Systems PMCF: A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems

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

Condition
Hip Arthroplasty, Total
Intervention / Treatment

-

Contacts and Locations

Tulsa

Tulsa Bone & Joint Associates, Tulsa, Oklahoma, United States, 74146

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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:
  • * Gender
  • * Age at surgery
  • * Height/Weight
  • * Indication for surgery
  • * Prior Injuries/Surgeries on index hip
  • * Comorbidities
  • * Date of Surgery
  • * Type of Surgery (Primary / Revision)
  • * All component product information, including catalogue reference numbers.
  • * Adverse Event Information, if applicable
  • * 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:
  • * Gender
  • * Age at surgery
  • * Height/Weight
  • * Indication for surgery
  • * Prior Injuries/Surgeries on index hip
  • * Comorbidities
  • * Date of Surgery
  • * Type of Surgery (Primary / Revision)
  • * All component product information, including catalogue reference numbers.
  • * Adverse Event Information, if applicable
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Exactech,

Study Record Dates

2036-12-31