Subchondral CystsNCT03494660
SCP Hip Outcomes Study
An observational study of Subchondral Cysts and Subchondral Bone Edema, run by Zimmer Biomet at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subchondral Cysts, Subchondral Bone Edema, Bone Marrow Edema
- What is being tested?
- Subchondroplasty Procedure with AccuFill
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 77 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Mar 2018to 13 Jan 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 50 subjects, each 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.
Who may be able to join
- Candidates must meet ALL of the following:
- Surgeon considers the patient appropriate for the SCP Procedure of the hip.
- Subchondral bone defect(s) in the femoral head, femoral neck and/or acetabulum has been confirmed via radiographic finding on MRI or x-ray.
- Subject provides voluntary signature on the IRB approved Informed Consent Form.
- Subject is at least 18 years of age.
- Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol and complete outcome forms via email, telephone, in-person or by regular mail.
Who cannot join
- Candidates will be excluded if they meet ANY of the following:
- Subject has collapse of subchondral bone.
- Subject is pregnant at the time of surgery.
- Subject is incarcerated.
- Subject is involved in active litigation related to the condition being treated.
- Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43202
Andrews Research & Education Foundation
Gulf Breeze, Florida, 32561
University of Kentucky Research Foundation
Lexington, Kentucky, 40506
Eisenhower Desert Orthopedic Center
Rancho Mirage, California, 92270
OrthoIllinois
Rockford, Illinois, 61114
About this study
Official title: A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip
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.
Read the detailed description
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.
- Conditions
- Subchondral Cysts, Subchondral Bone Edema, Bone Marrow Edema, Insufficiency Fractures, Avascular Necrosis of Hip, Femoroacetabular Impingement
- Being tested
- Subchondroplasty Procedure with AccuFill
- Keywords
- Subchondroplasty, Bone Marrow Lesion, Arthroscopy, Bone Substitute Material, AccuFill, Subchondral Bone Defect
- Medical subject headings
- Bone Cysts, Fractures, Stress, Femoracetabular Impingement, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subchondroplasty Procedure with AccuFillDevice
Injection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the hip (Subchondroplasty (SCP) Procedure).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Years
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start27 Mar 2018
- Primary completion23 Oct 2023
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subchondral CystsStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494660
- Sponsor's protocol ID
- CSU2017-03KC
- Status last verified
- Sep 2024
- First submitted
- 3 Apr 2018
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip
- ClinicalTrials.gov ID
- NCT03494660
- Acronym / sponsor ID
- CSU2017-03KC
- Conditions
- Subchondral Cysts, Subchondral Bone Edema, Bone Marrow Edema, Insufficiency Fractures, Avascular Necrosis of Hip, Femoroacetabular Impingement
- Keywords
- Subchondroplasty, Bone Marrow Lesion, Arthroscopy, Bone Substitute Material, AccuFill, Subchondral Bone Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Posted 21 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 50 subjects, each 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.
Key inclusion criteria (6 listed)
- Candidates must meet ALL of the following:
Key exclusion criteria (6 listed)
- Candidates will be excluded if they meet ANY of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subchondroplasty Procedure with AccuFillInjection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the hip (Subchondroplasty (SCP) Procedure). | Device | – |
Primary outcome
Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years
Time frame: 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.
21 secondary outcomes
Pain and Functional Performance by Numeric Pain Scale (NPS)
Time frame: 2 weeks postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Time frame: 6 weeks postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Time frame: 12 weeks postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Time frame: 6 months postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Time frame: 1 year postoperative
Pain and Functional Performance by Numeric Pain Scale (NPS)
Time frame: 2 years postoperative
Modified Harris Hip Score (mHHS)
Time frame: 6 weeks postoperative
Modified Harris Hip Score (mHHS)
Time frame: 12 weeks postoperative
Modified Harris Hip Score (mHHS)
Time frame: 6 months postoperative
Modified Harris Hip Score (mHHS)
Time frame: 1 year postoperative
Modified Harris Hip Score (mHHS)
Time frame: 2 years postoperative
Subject Quality-of-life Measured by the EQ-5D-5L Score
Time frame: 6 weeks
Subject Quality-of-life Measured by the EQ-5D-5L Score
Time frame: 12 weeks
Subject Quality-of-life Measured by the EQ-5D-5L Score
Time frame: 6 months
Subject Quality-of-life Measured by the EQ-5D-5L Score
Time frame: 1 Year
Subject Quality-of-life Measured by the EQ-5D-5L Score
Time frame: 2 Years
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Time frame: 6 Weeks
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Time frame: 12 Weeks
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Time frame: 6 Months
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Time frame: 1 Year
Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS)
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Subchondroplasty® (SCP®) ProcedureLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subchondral Cysts and Subchondral Bone Edema, run by Zimmer Biomet at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.