Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT02682602
Eligibility Criteria:
Inclusion Criteria for diseased/implanted subjects:
* Subjects will require a THA and will be implanted with either Summit/Pinnacle THA or Corail/Pinnacle THA.
* Patients must be at least six months post-operative with no other surgical procedures conducted within the past six months that will prohibit them from performing the study activities.
* Patients must be between 40-85 years of age.
* Potential subjects will have a body weight of less than 250 lbs.
* Participants must have Body Mass Index (BMI) of less than 38.
* Potential subjects' THAs should be judged clinically successful with a HHS \>90.
* Subjects must have demonstrated no evidence of post-operative hip subluxation or dislocation.
* Subjects must not walk with a detectable limp and must be able to actively abduct their operated hip against gravity without difficulty.
* Participants must be able to walk on level ground, ascend and descend a ramp and rise from a chair without assistance.
* Patients from the physician's list who do not meet the study requirements will not be considered.
* Patients must be willing to sign the Informed Consent (IC)/HIPAA form to participate in the study.
Exclusion Criteria for diseased/implanted subjects:
* Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
* Subjects without one of the two types of required hip implants.
* Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.
* Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.
* Subjects with pain, functional deficits, or generalized inflammatory.
* Subjects who walk with a detectable limp.
* Subjects who cannot actively abduct their operated hip against gravity without difficulty.
* Subjects who are unwilling to sign IC/HIPAA document.
* Subjects who have a HHS \<90.
Inclusion Criteria for normal subjects:
* Patients must not have any kind of hip implant.
* Subjects must not have had any type of hip surgery or any pathological hip conditions, including osteoarthritis, or hip pain.
* Patients must be between the ages of 18 and 65.
* Potential subjects will have a body weight of less than 250 lbs.
* Participants must have BMI of less than 38.
* Pregnant or potentially pregnant females will be excluded from the study. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
* Participants must be able to walk on level ground, ascend and descend a ramp and rise from a chair without aid of any kind or have had any kind of surgical procedure within the past 6 months that would affect his/her ability to perform the study activities.
* Patients must be willing to sign the IC and HIPAA forms to participate in the study.
* Patients must be between 160cm (5'3) and 193cm (6'4) tall
Exclusion Criteria for normal subjects:
* Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study
* Subjects with any kind of hip implant.
* Subjects who have had any past hip surgery, have pathological hip conditions and/or hip pain.
* Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.
* Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.
* Subjects who are unwilling to sign IC/HIPAA document.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT02682602
Study Brief:
Protocol Section:
NCT02682602