Trial Outcomes & Findings for The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction (NCT NCT04533880)
NCT ID: NCT04533880
Last Updated: 2024-08-13
Results Overview
The KOOS survery comprises 42 questions; questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), quality of life (4 questions). Each item is rated on a Likert scale from 0 to 4. The score is calculated by summing the responses. The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain / higher difficulty in function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Month 12 Post-Op
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Control
The control group will receive autologous bone obtained from the BTBPB graft harvest
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + DBM
Autologous bone plus demineralized bone matrix
DBM: Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + Calcium Phosphate Cement
Autologous bone plus calcium phosphate cement
Calcium phosphate cement: Quickset, Arthrex, Naples, FL
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
48
|
|
Overall Study
COMPLETED
|
52
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Control
The control group will receive autologous bone obtained from the BTBPB graft harvest
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + DBM
Autologous bone plus demineralized bone matrix
DBM: Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + Calcium Phosphate Cement
Autologous bone plus calcium phosphate cement
Calcium phosphate cement: Quickset, Arthrex, Naples, FL
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction
Baseline characteristics by cohort
| Measure |
Control
n=52 Participants
The control group will receive autologous bone obtained from the BTBPB graft harvest
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + DBM
n=49 Participants
Autologous bone plus demineralized bone matrix
DBM: Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + Calcium Phosphate Cement
n=47 Participants
Autologous bone plus calcium phosphate cement
Calcium phosphate cement: Quickset, Arthrex, Naples, FL
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
28.8 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
28.8 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
28.43 years
STANDARD_DEVIATION 7.13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
49 participants
n=7 Participants
|
47 participants
n=5 Participants
|
148 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Month 12 Post-OpThe KOOS survery comprises 42 questions; questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), quality of life (4 questions). Each item is rated on a Likert scale from 0 to 4. The score is calculated by summing the responses. The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain / higher difficulty in function.
Outcome measures
| Measure |
Control
n=52 Participants
The control group will receive autologous bone obtained from the BTBPB graft harvest
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + DBM
n=49 Participants
Autologous bone plus demineralized bone matrix
DBM: Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + Calcium Phosphate Cement
n=47 Participants
Autologous bone plus calcium phosphate cement
Calcium phosphate cement: Quickset, Arthrex, Naples, FL
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
|---|---|---|---|
|
Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey
|
67 score on a scale
Standard Deviation 6.1
|
69 score on a scale
Standard Deviation 6.3
|
67.7 score on a scale
Standard Deviation 8.2
|
PRIMARY outcome
Timeframe: Month 12 Post-OpThe Kujala AKPS is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. The total score is the sum of responses; total scores range from 0 to 100. Lower scores indicate greater signs of knee pain.
Outcome measures
| Measure |
Control
n=52 Participants
The control group will receive autologous bone obtained from the BTBPB graft harvest
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + DBM
n=49 Participants
Autologous bone plus demineralized bone matrix
DBM: Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + Calcium Phosphate Cement
n=47 Participants
Autologous bone plus calcium phosphate cement
Calcium phosphate cement: Quickset, Arthrex, Naples, FL
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
|---|---|---|---|
|
Score on Kujala Anterior Knee Pain Scale (AKPS)
|
87.1 score on a scale
Standard Deviation 11
|
85.7 score on a scale
Standard Deviation 17
|
86.2 score on a scale
Standard Deviation 12.1
|
PRIMARY outcome
Timeframe: Baseline, Month 12 Post-OpThe visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The total score range is 0-100; the higher the score, the worse the pain.
Outcome measures
| Measure |
Control
n=52 Participants
The control group will receive autologous bone obtained from the BTBPB graft harvest
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + DBM
n=49 Participants
Autologous bone plus demineralized bone matrix
DBM: Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
Autologous Bone + Calcium Phosphate Cement
n=47 Participants
Autologous bone plus calcium phosphate cement
Calcium phosphate cement: Quickset, Arthrex, Naples, FL
Autologous bone graft: Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
|
|---|---|---|---|
|
Change in VAS Score for Anterior Knee Pain
|
-5.5 score on a scale
Standard Deviation 24.3
|
-8.4 score on a scale
Standard Deviation 26.9
|
1 score on a scale
Standard Deviation 26.4
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Autologous Bone + DBM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Autologous Bone + Calcium Phosphate Cement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place