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Exactech Hip Systems Post-Market Clinical Follow-up

This study is looking at how well Exactech Hip Systems work for people who have had or will have a total hip arthroplasty (THA), which is a surgery to replace your hip joint. Researchers want to collect information on how patients do after receiving these hip systems. They will measure your hip function using the Harris Hip Score before your surgery, and then again 4-6 weeks and 3-6 months after your surgery. You can join if you are 18 years or older, are having an Exactech Hip System for your hip replacement, and are willing to participate. The study aims to include about 2946 people.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include about 2946 participants.
What's involved
You would need to agree to participate and provide written consent. Your hip function will be measured at specific times before and after your hip replacement surgery.
Compensation
Not stated in the trial record.
Follow-up
Your hip function will be measured up to 3-6 months after your surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05849961

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

Recruiting
Not specifiedAges 18+Observational
Exactech
~2,946 participants
Updated 2024-06-18 on ClinicalTrials.gov
What's tested:Exactech Hip Systems

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Harris Hip Score
Measured over Preoperative
+7 more outcomes measured

Conditions

Hip Arthroplasty, Total

Explore related trials

Repair of hip

NCT05849961

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Tulsa Bone & Joint Associates

    Tulsa, Oklahomastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Pearl Harris
[email protected]
352-377-1140
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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.
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.
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

Exclusion

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)

What this trial measures

  • Harris Hip ScorePreoperative

    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.

  • Harris Hip Score4-6 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.

  • Harris Hip Score3-6 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.

  • Harris Hip ScoreAnnually 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.

  • Oxford Hip ScorePreoperative

    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.

  • Oxford Hip Score4-6 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.

  • Oxford Hip Score3-6 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.

  • Oxford Hip ScoreAnnually 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.