Clinical trial Recruiting at 1 site Observational Ages 18 and up

Collecting data on Exactech Hip Systems after surgery

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

Run by Exactech · NCT05849961 · Data updated 2026-11-12

This study is collecting information from people who have had or will have an Exactech Hip System to see how well it works and how safe it is after surgery.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment2946 (estimated)
SponsorExactech
Industry-sponsored
Locations1 site (Tulsa, Oklahoma)
StatusRecruiting
StartedOctober 13, 2023
Main results expectedJuly 31, 2036
Study endsDecember 31, 2036
Registry record updatedJune 18, 2024
Trial IDNCT05849961 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older who are scheduled to receive or have already received an Exactech Hip System for total hip arthroplasty.

Probably not a fit

Patients who have not received an Exactech Hip System or those who are not eligible for hip arthroplasty may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather clinical and patient outcomes data for individuals who have received or will receive an Exactech Hip System for total hip arthroplasty. It includes both prospective data collection from new patients and retrospective data from patients who have already undergone surgery. The study focuses on assessing the safety and effectiveness of these orthopedic devices in real-world settings. By analyzing this data, the study seeks to provide insights into the survivorship and performance of Exactech Hip Systems.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of the long-term safety and effectiveness of Exactech Hip Systems, leading to improved patient outcomes.

How similar studies have gone: Other studies assessing post-market outcomes of orthopedic devices have shown success in improving device safety and effectiveness, making this approach both relevant and valuable.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • Tulsa Bone & Joint Associates
    Tulsa, Oklahoma, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Supra-inguinal fascia iliaca nerve block for pain after hip replacement

    This project will try a supra-inguinal fascia iliaca nerve block during primary total hip replacement to see if it reduces pain and the need for opioids afterward.

    Recruiting Institut Mutualiste Montsouris · Paris · NCT06982625

  • Is a one-year routine check-up needed after hip or knee replacement?

    This study will see if skipping the routine one-year clinic visit and using check-up on demand is safe and works well for people aged 50 and older after total hip or knee replacement.

    Recruiting at 9 sites JointResearch · Amsterdam and 8 other locations · NCT06971757

  • Gait mechanics and return to sport after total hip replacement

    This project tries to measure walking and movement patterns in active adults having a total hip replacement to see how those patterns relate to getting back to sports.

    Recruiting Clinique du Sport, Bordeaux Mérignac · Mérignac · NCT06803914

  • Tele-rehabilitation after total hip replacement

    This project tests whether remote (tele-)rehabilitation helps people recover better after total hip replacement than receiving no physical therapy.

    Recruiting Clinique du Sport, Bordeaux Mérignac · Mérignac · NCT06780319

  • Shorter anticoagulation after hip surgery to prevent blood clots

    This study is testing if a shorter 10-day treatment with a blood thinner after hip surgery can prevent blood clots just as well as the usual 35-day treatment for patients recovering from the surgery.

    Recruiting at 6 sites Phase 3 Johannes Gutenberg University Mainz · Linz, Upper Austria and 5 other locations · NCT06611319

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.