Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain, function, activity levels and patient satisfaction.
This study is designed as a post-market, single arm, non-randomized multi-center investigation. Male and female subjects, at least 18 years of age, with at least one subchondral bone defect in the form of a cyst and/or bone marrow lesion (BML), insufficiency fracture or bone defect associated with early stage avascular osteonecrosis (AVN) in the femoral head, femoral neck and/or acetabulum who are suitable candidates for use of AccuFill during the Subchondroplasty Procedure are eligible for enrollment in this study. A maximum of 15 study sites, in the United States of America, will enroll a target of 50 subjects. Each Investigator must obtain IRB approval, or favorable opinion by an EC, prior to consent of the first subject; no study-related procedures can occur without the approval and oversight of a registered IRB or EC. If the study site does not have an IRB of record, a central IRB may be utilized upon approval by Zimmer Biomet. Demographics, medical history, hip history and use of pain medication and therapy will be recorded at the time of subject consent. Additionally, patient reported outcomes measures will be obtained pre-operatively. Operative details including the SCP Procedure, concomitant surgical procedures and intraoperative safety events will be recorded at the time of surgery. Prospective subjects will be considered enrolled in this study once their Subchondroplasty Procedure has been performed. Subjects will complete only the Numeric Pain Scale at 2 weeks post-operatively. Thereafter, subjects will complete self-reported outcomes measures post-operatively at 6 weeks, 12 weeks, 6 months, 1 year and 2 years. These measures include information on pain medication and therapy, pain levels, function, activity and subject satisfaction. Screening for adverse events and conversion will occur throughout the study. Subjects will complete the study at 2 years or will be withdrawn if they undergo conversion of the Subchondroplasty site. For the purposes of this protocol, a conversion will be defined as total hip arthroplasty or any procedure involving removal of the AccuFill material on the index hip.
Study Type
OBSERVATIONAL
Enrollment
77
Injection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the hip (Subchondroplasty (SCP) Procedure).
Eisenhower Desert Orthopedic Center
Rancho Mirage, California, United States
Andrews Research & Education Foundation
Gulf Breeze, Florida, United States
OrthoIllinois
Rockford, Illinois, United States
University of Kentucky Research Foundation
Lexington, Kentucky, United States
Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years
Change in Modified Harris Hip Score using a 0-100 overall score, from baseline at 2-years. Subscales of pain, function, and activity levels are combined to generate the overall score. Pain is scored out of 44 possible points, function is scored out of 33 possible points and subject activities are scored out of 14 possible points. The maximum score of 91 is multiplied by 1.1 to give a total score out of 100; a higher score represents better patient reported pain, function and activity levels.
Time frame: 2 Years
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 2 weeks postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 6 weeks postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 12 weeks postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 6 months postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 1 year postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame: 2 years postoperative
Modified Harris Hip Score (mHHS)
Hip function and pain were assessed using the Modified Harris Hip Score (mHHS), a validated instrument that evaluates pain, daily activities, and gait. Scores range from 0 to 100, where higher scores indicate better hip function and less pain. Change from baseline was calculated at each follow-up timepoint.
Time frame: 6 weeks postoperative
Modified Harris Hip Score (mHHS)
Hip function and pain were assessed using the Modified Harris Hip Score (mHHS), a validated instrument that evaluates pain, daily activities, and gait. Scores range from 0 to 100, where higher scores indicate better hip function and less pain. Change from baseline was calculated at each follow-up timepoint.
Time frame: 12 weeks postoperative
Modified Harris Hip Score (mHHS)
Hip function and pain were assessed using the Modified Harris Hip Score (mHHS), a validated instrument that evaluates pain, daily activities, and gait. Scores range from 0 to 100, where higher scores indicate better hip function and less pain. Change from baseline was calculated at each follow-up timepoint.
Time frame: 6 months postoperative
Modified Harris Hip Score (mHHS)
Hip function and pain were assessed using the Modified Harris Hip Score (mHHS), a validated instrument that evaluates pain, daily activities, and gait. Scores range from 0 to 100, where higher scores indicate better hip function and less pain. Change from baseline was calculated at each follow-up timepoint.
Time frame: 1 year postoperative
Modified Harris Hip Score (mHHS)
Hip function and pain were assessed using the Modified Harris Hip Score (mHHS), a validated instrument that evaluates pain, daily activities, and gait. Scores range from 0 to 100, where higher scores indicate better hip function and less pain. Change from baseline was calculated at each follow-up timepoint.
Time frame: 2 years postoperative
Subject Quality-of-life Measured by the EQ-5D-5L Score
Quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses will be converted into a single utility index score using the appropriate value set, with values typically ranging from 0 (worst health) to 1 (best health). Higher scores indicate better quality of life.
Time frame: 6 weeks
Subject Quality-of-life Measured by the EQ-5D-5L Score
Quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses will be converted into a single utility index score using the appropriate value set, with values typically ranging from 0 (worst health) to 1 (best health). Higher scores indicate better quality of life.
Time frame: 12 weeks
Subject Quality-of-life Measured by the EQ-5D-5L Score
Quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses will be converted into a single utility index score using the appropriate value set, with values typically ranging from 0 (worst health) to 1 (best health). Higher scores indicate better quality of life.
Time frame: 6 months
Subject Quality-of-life Measured by the EQ-5D-5L Score
Quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses will be converted into a single utility index score using the appropriate value set, with values typically ranging from 0 (worst health) to 1 (best health). Higher scores indicate better quality of life.
Time frame: 1 Year
Subject Quality-of-life Measured by the EQ-5D-5L Score
Quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. Responses will be converted into a single utility index score using the appropriate value set, with values typically ranging from 0 (worst health) to 1 (best health). Higher scores indicate better quality of life.
Time frame: 2 Years
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
The EQ-5D-5L VAS records the subject's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: 6 Weeks
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
The EQ-5D-5L VAS records the subject's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: 12 Weeks
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
The EQ-5D-5L VAS records the subject's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: 6 Months
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
The EQ-5D-5L VAS records the subject's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: 1 Year
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
The EQ-5D-5L VAS records the subject's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: 2 Years