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

NCT05849961 | Recruiting FDA Device

• 1 other identifier: TM-2023-017318
• Study Type: observational
• Target: 2,946
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Arthroplasty, Total

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Annually up to 10 years; per standard of care

Study Arms (3)

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

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

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

Interventions

Exactech Hip Systems DEVICE

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.

Prospective Subjects; Retrospective Only Subjects; Retrospective to Prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exactech: lead

Study Sites (1)

Tulsa Bone & Joint Associates

Tulsa, Oklahoma, 74146, United States

RECRUITING

Central Study Contacts

Pearl Harris

CONTACT

352-377-1140; pearl.harris@exac.com

Alex Knisely

CONTACT

352-474-9582; alex.knisely@exac.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 9, 2023
• Study Start: October 13, 2023
• Primary Completion (Estimated): July 31, 2036
• Study Completion (Estimated): December 31, 2036
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

US (1)