Trial Outcomes & Findings for Study on Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head (NCT NCT01529008)
NCT ID: NCT01529008
Last Updated: 2022-06-24
Results Overview
A patient was considered as having responded to treatment if: * the WOMAC VA3.1 pain subscale score (Western Ontario and McMaster Universitie Visual Analogue scale) of the study treated hip improved from baseline by at leat the MCID (minimal clinically important difference ) the WOMAC VA3.1 pain subscale score is Visual score based on 10 cm and * the study treated hip did not progress to fractural stages (ARCO III or higher) as assessed by conventional X-ray
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
68 participants
Primary outcome timeframe
24 months
Results posted on
2022-06-24
Participant Flow
the Data Safety Monitoring Board recommended that the study be stopped for futility
Participant milestones
| Measure |
Core Decompression/PREOB® Implantation
Core decompression/PREOB® implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
|
Core Decompression/Placebo Implantation
Core decompression/placebo implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
|
|---|---|---|
|
Screening
STARTED
|
35
|
33
|
|
Screening
COMPLETED
|
35
|
33
|
|
Screening
NOT COMPLETED
|
0
|
0
|
|
Bone Marrow Harvesting
STARTED
|
35
|
33
|
|
Bone Marrow Harvesting
COMPLETED
|
34
|
30
|
|
Bone Marrow Harvesting
NOT COMPLETED
|
1
|
3
|
|
Treatment
STARTED
|
34
|
30
|
|
Treatment
COMPLETED
|
25
|
29
|
|
Treatment
NOT COMPLETED
|
9
|
1
|
|
Efficacy Analysis
STARTED
|
25
|
29
|
|
Efficacy Analysis
COMPLETED
|
23
|
26
|
|
Efficacy Analysis
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Core Decompression/PREOB® Implantation
Core decompression/PREOB® implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
|
Core Decompression/Placebo Implantation
Core decompression/placebo implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
|
|---|---|---|
|
Bone Marrow Harvesting
Physician Decision
|
1
|
1
|
|
Bone Marrow Harvesting
Withdrawal by Subject
|
0
|
2
|
|
Treatment
Adverse Event
|
6
|
0
|
|
Treatment
Other
|
3
|
1
|
|
Efficacy Analysis
Protocol Violation
|
2
|
0
|
|
Efficacy Analysis
Physician Decision
|
0
|
1
|
|
Efficacy Analysis
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Study on Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head
Baseline characteristics by cohort
| Measure |
Core Decompression/PREOB® Implantation
n=34 Participants
Core decompression/PREOB® implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
|
Core Decompression/Placebo Implantation
n=30 Participants
Core decompression/placebo implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
45.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · Caucasian/White
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · Black
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · Oriental/Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Full Analysis Set (FAS)
A patient was considered as having responded to treatment if: * the WOMAC VA3.1 pain subscale score (Western Ontario and McMaster Universitie Visual Analogue scale) of the study treated hip improved from baseline by at leat the MCID (minimal clinically important difference ) the WOMAC VA3.1 pain subscale score is Visual score based on 10 cm and * the study treated hip did not progress to fractural stages (ARCO III or higher) as assessed by conventional X-ray
Outcome measures
| Measure |
Core Decompression/PREOB® Implantation
n=23 Participants
Core decompression/PREOB® implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
|
Core Decompression/Placebo Implantation
n=26 Participants
Core decompression/placebo implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
|
|---|---|---|
|
Percentage of Treatment Responders
|
60.9 percentage of treatment responders
Interval 38.5 to 80.3
|
69.2 percentage of treatment responders
Interval 48.2 to 85.7
|
Adverse Events
Core Decompression/PREOB® Implantation
Serious events: 16 serious events
Other events: 22 other events
Deaths: 0 deaths
Core Decompression/Placebo Implantation
Serious events: 18 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Core Decompression/PREOB® Implantation
n=25 participants at risk
Core decompression/PREOB® implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
|
Core Decompression/Placebo Implantation
n=29 participants at risk
Core decompression/placebo implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Number of events 1 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
General disorders
disease progression
|
28.0%
7/25 • Number of events 9 • 24 months
|
48.3%
14/29 • Number of events 17 • 24 months
|
|
General disorders
Chest pain
|
4.0%
1/25 • Number of events 1 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Colitis ulcerative
|
8.0%
2/25 • Number of events 2 • 24 months
|
0.00%
0/29 • 24 months
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Number of events 2 • 24 months
|
0.00%
0/29 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Umbilical Hernia
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Breathing-related sleep disorder
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Infections and infestations
Apendicitis
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Infections and infestations
Campylobacter Infection
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Infections and infestations
Cholangitis Infective
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Infections and infestations
Cytomegalovirus Gastroenteritis
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Renal and urinary disorders
Acute renal kidney
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Social circumstances
Hip Arthroplasty
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 2 • 24 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
4.0%
1/25 • Number of events 2 • 24 months
|
0.00%
0/29 • 24 months
|
|
Immune system disorders
Lung transplant rejection
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Investigations
Transplant evaluation
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Nervous system disorders
Amnesia
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
|
Skin and subcutaneous tissue disorders
Angiodema
|
0.00%
0/25 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Infections and infestations
Lung infection
|
4.0%
1/25 • Number of events 1 • 24 months
|
0.00%
0/29 • 24 months
|
Other adverse events
| Measure |
Core Decompression/PREOB® Implantation
n=25 participants at risk
Core decompression/PREOB® implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
|
Core Decompression/Placebo Implantation
n=29 participants at risk
Core decompression/placebo implantation: All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
48.0%
12/25 • Number of events 18 • 24 months
|
44.8%
13/29 • Number of events 19 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
12.0%
3/25 • Number of events 3 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Number of events 1 • 24 months
|
6.9%
2/29 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.0%
1/25 • Number of events 1 • 24 months
|
6.9%
2/29 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.0%
1/25 • Number of events 1 • 24 months
|
6.9%
2/29 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/25 • 24 months
|
10.3%
3/29 • Number of events 3 • 24 months
|
|
General disorders
Pain
|
4.0%
1/25 • Number of events 1 • 24 months
|
6.9%
2/29 • Number of events 2 • 24 months
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
4.0%
1/25 • Number of events 1 • 24 months
|
6.9%
2/29 • Number of events 2 • 24 months
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
4/25 • Number of events 4 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/25 • 24 months
|
6.9%
2/29 • Number of events 2 • 24 months
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Number of events 2 • 24 months
|
3.4%
1/29 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
12.0%
3/25 • Number of events 3 • 24 months
|
0.00%
0/29 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place