RECRUITING

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

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Conditions

Hip Arthroplasty, Total

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-10-13
Study Completion:2036-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05849961

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
  2. * Skeletally mature (18 years of age or older).
  3. * The subject is willing and able to provide written informed consent for participation in the study.
  4. * Subject is to receive an Exactech Hip System THA for any approved indication for use.
  5. * The hip replacement will be performed by the investigator or a surgeon sub- investigator.
  6. * The devices will be used according to the approved indications.
  7. * 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).
  8. * Skeletally mature (18 years of age or older).
  9. * The subject is willing and able to provide written informed consent for participation in the study.
  10. * Subject received an Exactech Hip System THA for any approved indication for use.
  11. * The hip replacement was performed by the investigator or a surgeon sub-investigator.
  12. * The devices are/were used according to the approved indications.
  13. * 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:
  14. * Gender
  15. * Age at surgery
  16. * Height/Weight
  17. * Indication for surgery
  18. * Prior Injuries/Surgeries on index hip
  19. * Comorbidities
  20. * Date of Surgery
  21. * Type of Surgery (Primary / Revision)
  22. * All component product information, including catalogue reference numbers.
  23. * Adverse Event Information, if applicable
  24. * Skeletally mature (18 years of age or older).
  25. * The subject is willing and able to provide written informed consent for participation in the study.
  26. * Subject received an Exactech Hip System THA for any approved indication for use.
  27. * The hip replacement was performed by the investigator or a surgeon sub-investigator.
  28. * The devices are/were used according to the approved indications.
  29. * 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:
  30. * Gender
  31. * Age at surgery
  32. * Height/Weight
  33. * Indication for surgery
  34. * Prior Injuries/Surgeries on index hip
  35. * Comorbidities
  36. * Date of Surgery
  37. * Type of Surgery (Primary / Revision)
  38. * All component product information, including catalogue reference numbers.
  39. * Adverse Event Information, if applicable
  1. * Patient was \<18 years of age at time of surgery
  2. * Patient does not meet the indicated population for use criteria for this device.
  3. * Patient is pregnant
  4. * Patient is a prisoner
  5. * Patient has a physical or mental condition that would invalidate the results
  6. * Patient is contraindicated for the surgery (e.g., metal allergy)

Contacts and Locations

Study Contact

Pearl Harris
CONTACT
352-377-1140
pearl.harris@exac.com
Alex Knisely
CONTACT
352-474-9582
alex.knisely@exac.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2023-10-13
Study Completion Date2036-12-31

Study Record Updates

Study Start Date2023-10-13
Study Completion Date2036-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Hip Arthroplasty, Total