Trial Outcomes & Findings for SCP® Observational Study of the Knee (NCT NCT03110224)
NCT ID: NCT03110224
Last Updated: 2025-10-28
Results Overview
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.
Recruitment status
TERMINATED
Target enrollment
516 participants
Primary outcome timeframe
12 months
Results posted on
2025-10-28
Participant Flow
Of 516 patients enrolled, 508 had data entered that could be used for analysis.
Participant milestones
| Measure |
Subchondroplasty
Patients who were to undergo Subchondroplasty
|
|---|---|
|
Overall Study
STARTED
|
516
|
|
Overall Study
COMPLETED
|
133
|
|
Overall Study
NOT COMPLETED
|
383
|
Reasons for withdrawal
| Measure |
Subchondroplasty
Patients who were to undergo Subchondroplasty
|
|---|---|
|
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
2 patients did not have age entered at baseline
Baseline characteristics by cohort
| Measure |
Baseline
n=516 Participants
Demographics of patients enrolled in the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=514 Participants • 2 patients did not have age entered at baseline
|
|
Age, Categorical
Between 18 and 65 years
|
299 Participants
n=514 Participants • 2 patients did not have age entered at baseline
|
|
Age, Categorical
>=65 years
|
215 Participants
n=514 Participants • 2 patients did not have age entered at baseline
|
|
Age, Continuous
Age
|
56.77 years
STANDARD_DEVIATION 12.63 • n=514 Participants • 2 patients did not have age entered at baseline.
|
|
Sex: Female, Male
Female
|
272 Participants
n=508 Participants • Gender not entered for 8 patients
|
|
Sex: Female, Male
Male
|
236 Participants
n=508 Participants • Gender not entered for 8 patients
|
|
Region of Enrollment
United States
|
516 Participants
n=516 Participants
|
|
BMI
|
31.53 kg/m2
STANDARD_DEVIATION 6.71 • n=504 Participants • BMI could not be calculated for 12 patients due to missing weight, height, or both.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Visual Analog Scale was analyzed at baseline to 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.
Outcome measures
| Measure |
Primary Outcome Measure
n=250 Participants
Visual Analog Scale measured at baseline and 12 months.
|
|---|---|
|
Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 Months
Baseline
|
6.8 score on a scale
Interval 6.6 to 7.0
|
|
Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 Months
12 Months
|
3.6 score on a scale
Interval 3.3 to 4.0
|
SECONDARY outcome
Timeframe: 5 yearsSummary and description of procedure and device related adverse events and surgical re-operations and relatedness to the bone substitute material and procedure
Outcome measures
| Measure |
Primary Outcome Measure
n=508 Participants
Visual Analog Scale measured at baseline and 12 months.
|
|---|---|
|
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
|
|
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
|
|
Occurences and Severity of Device and/or Procedure Related Adverse Events and Re-visions/Re-operations
Revisions
|
72 Number of Events Reported
|
Adverse Events
Adverse Events
Serious events: 83 serious events
Other events: 17 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Adverse Events
n=516 participants at risk
Adverse Events reported during the study.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Chondrosis: Patella and Medial Femoral Condyle
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Complex tear of medial meniscus of right knee
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Extensive chondrosis medial femoral condyle and medial tibial plateau
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
General disorders
Fall
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Increased grinding and retropatellar pain
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Infected right knee
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Known patellar chondrosis with recurrent effusions and pain
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
9.1%
47/516 • Number of events 49 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis with fracture
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Persistence of patellofemoral pain not responsive to conservative management.
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Post-operative pain
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Blood and lymphatic system disorders
Right Femoral Popliteal DVT
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Septic Knee
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Subchondral edema/stress fracture reaction medial femoral condyle and medial tibial plateau
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Left knee draining sinus
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal pain secondary to pancreatic cancer stage 2 A
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone marrow lesion in femur
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
General disorders
Cephalgia
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Complete tear of medial and lateral menisci
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Increased Knee Pain
|
2.1%
11/516 • Number of events 11 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
L4-5 Laminectomy w posterior fusion O-arm
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Gastrointestinal disorders
Laparoscopic sleeve gastrectomy w PEH repair for morbid obesity BMI 45.0-49.9
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Left shoulder scope w rotator cuff repair
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Parapatellar increased synovium and scar
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Persistently symptomatic chondral defect of patella
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Persistently symptomatic patellar cartilage defect
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Persistently symptomatic patellar chondrosis
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Eye disorders
Right Eye Cataract
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Right Knee arthroscopy (non study knee)
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff injury
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Total knee arthroplasty
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
Other adverse events
| Measure |
Adverse Events
n=516 participants at risk
Adverse Events reported during the study.
|
|---|---|
|
Gastrointestinal disorders
Acute Cholecystitis
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthroscopic Surgery
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Difficulty with dorsiflexion of left foot.
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Increased Knee Pain
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Left elbow pain
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Left knee draining sinus
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Left knee stress fracture lateral femoral condyle and impending OCD lesion
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Medial femoral condyle insufficiency fracture
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
General disorders
Patient had signs of delirium postoperatively
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Right knee chondromalacia patella with right thigh muscle/tendon strain.
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Stress fracture left foot
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Gastrointestinal disorders
GI virus
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Patient reported knee popping with pain
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Total knee arthroplasty
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
|
Musculoskeletal and connective tissue disorders
Unicompartment knee replacement
|
0.19%
1/516 • Number of events 1 • Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place