Bone Marrow Edema
Conditions
Keywords
Subchondroplasty, Bone Marrow Lesion, Arthroscopy, Bone Substitute Material, AccuFill, Subchondral Bone Defect
Brief summary
Post Market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the Subchondroplasty (SCP) Procedure in the knee in a standard clinical setting. Outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.
Detailed description
This is a post-market, multi-center, patient outcomes centered study to evaluate the on-label use of AccuFill during the Subchondroplasty procedure. Enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one Bone Marrow Lesion (BML) in the knee. Demographics, medical history and medications will recorded at the time of enrollment. Surgical details including the SCP procedure, concomitant surgical procedures and intraoperative safety events will be recorded. Subjects will complete patient reported outcomes measures pre-operatively including the Visual Analog Scale (VAS) for knee pain, International Knee Documentation Committee Subject Knee (IKDC) Form and the Veterans Rand 12 (VR-12) Item Health Survey. These measures will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. Screening for adverse events and revision surgeries will occur throughout the study. Target enrollment is 1000 subjects at up to 30 clinical sites. Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.
Interventions
Injection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the knee(Subchondroplasty (SCP) Procedure).
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Surgeon considers patient appropriate for SCP procedure. 2. Patient has agreed to undergo the SCP procedure or has already undergone the procedure. 3. Subject is willing and able to sign a written consent form. 4. The subject has the mental capacity and the willingness to contribute follow-up outcome data. 5. Patient is willing and able to complete outcome forms in person or by phone, email or regular mail.
Exclusion criteria
1\. Patient is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 Months | 12 months | Change from baseline score of pain intensity at 12 months. To collect VAS, patients marked a slash on a 10 cm horizontal line, with 0 cm indicating no pain and 10 cm indicating worst possible pain. The distance from the left end of the line to the patient's mark was measured by the administrator in centimeters. Lower numbers were representative of lower pain levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurences and Severity of Device and/or Procedure Related Adverse Events and Re-visions/Re-operations | 5 years | Summary and description of procedure and device related adverse events and surgical re-operations and relatedness to the bone substitute material and procedure |
Countries
United States
Participant flow
Pre-assignment details
Of 516 patients enrolled, 508 had data entered that could be used for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Baseline Demographics of patients enrolled in the study. | 516 |
| Total | 516 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 132 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Site Closed by Physician | 35 |
| Overall Study | Site Closed by Sponsor | 202 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Baseline | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 215 Participants | — |
| Age, Categorical Between 18 and 65 years | 299 Participants | — |
| Age, Continuous Age | 56.77 years STANDARD_DEVIATION 12.63 | — |
| BMI | 31.53 kg/m2 STANDARD_DEVIATION 6.71 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 516 Participants | — |
| Sex: Female, Male Female | 272 Participants | — |
| Sex: Female, Male Male | 236 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 516 |
| other Total, other adverse events | 17 / 516 |
| serious Total, serious adverse events | 83 / 516 |
Outcome results
Primary
Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 Months
Change from baseline score of pain intensity at 12 months. To collect VAS, patients marked a slash on a 10 cm horizontal line, with 0 cm indicating no pain and 10 cm indicating worst possible pain. The distance from the left end of the line to the patient's mark was measured by the administrator in centimeters. Lower numbers were representative of lower pain levels.
Time frame: 12 months
Population: Visual Analog Scale was analyzed at baseline to 12 months.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Primary Outcome Measure | Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 Months | Baseline | 6.8 score on a scale |
| Primary Outcome Measure | Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 Months | 12 Months | 3.6 score on a scale |
Secondary
Occurences and Severity of Device and/or Procedure Related Adverse Events and Re-visions/Re-operations
Summary and description of procedure and device related adverse events and surgical re-operations and relatedness to the bone substitute material and procedure
Time frame: 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Outcome Measure | Occurences and Severity of Device and/or Procedure Related Adverse Events and Re-visions/Re-operations | Events Related to SCP | 36 Number of Events Reported |
| Primary Outcome Measure | Occurences and Severity of Device and/or Procedure Related Adverse Events and Re-visions/Re-operations | Events Unrelated to SCP | 72 Number of Events Reported |
| Primary Outcome Measure | Occurences and Severity of Device and/or Procedure Related Adverse Events and Re-visions/Re-operations | Revisions | 72 Number of Events Reported |