Phase III, pivotal, multicentre, randomised, double-blind controlled Study to evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head.

Phase III, pivotal, multicentre, randomised, double-blind controlled Study to evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head. - Efficacy and safety of autologous bone transplant for femoral head necrosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45063

Enrollment

Registered

2012-09-25

Start date

2014-10-28

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nontraumatic osteonecrosis of the femoral head Tissuedegeneration in femoral head

Interventions

Study group: Core decompression with a small-diameter trephine and implantation of 5ml PREOB® solution (at concentration of 4*10^6 cells/ml - PREOB®20) into the necrotic lesion. Control group: Core

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men and women, aged 18 to 70 years old, diagnosed with: - an ARCO stage I osteonecrosis with the sum of coronal and sagittal necrotic angles superior to 190 degrees which is symptomatic (pain * 20 mm on the WOMAC® VA3.1 pain subscale during the 48 hours preceding the screening) - an ARCO stage II osteonecrosis with the sum of coronal and sagittal necrotic angles superior to 190 degrees which can be either symptomatic or asymptomatic - an ARCO stage II osteonecrosis with the sum of coronal and sagittal necrotic angles inferior to 190 degrees which is symptomatic (pain * 20 mm on the WOMAC® VA3.1 pain subscale during the 48 hours preceding)

Exclusion criteria

Exclusion criteria: ARCO stage III and IV osteonecrosis of the femoral head on the hip which is evaluated, and confirmed by conventional X-ray and and MRI of the hip. Osteoarthritis on the hip. Bone fracture that might interfere with study evaluation.

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Endpoint - Percentage of treatment responders at Month 24, a treatment responder at the studied timepoint being defined as a patient who responded both: --Clinically, i.e., if at the studied timepoint, the WOMAC® VA3.1 pain subscale score of the study treated hip improved from baseline by at least the minimal clinically important difference (MCID), and --Radiologically, i.e., if at the studied timepoint, the study treated hip did not progress to fractural stages (ARCO III or higher), as assessed by conventional X-ray.	—

Measure

Time frame

Primary Efficacy Endpoint - Percentage of treatment responders at Month 24, a treatment responder at the studied timepoint being defined as a patient who responded both: --Clinically, i.e., if at the studied timepoint, the WOMAC® VA3.1 pain subscale score of the study treated hip improved from baseline by at least the minimal clinically important difference (MCID), and --Radiologically, i.e., if at the studied timepoint, the study treated hip did not progress to fractural stages (ARCO III or higher), as assessed by conventional X-ray.

—

Secondary

Measure	Time frame
- Percentage of treatment responders at Month 6, 12 and 18, and over the 24-month follow-up period - Percentage of clinical responders at Month 1, 3, 6, 12, 18 and 24, and over the 24month follow-up period - Percentage of radiological responders at Month 6, 12, 18 and 24, and over the 24month follow-up period - Absolute change from baseline in WOMAC® VA3.1 total score and composite pain, stiffness, and function subscales scores - Time to hip fracture - Time to hip arthroplasty - Percentage of patients requiring hip arthroplasty	—

Measure

Time frame

- Percentage of treatment responders at Month 6, 12 and 18, and over the 24-month follow-up period - Percentage of clinical responders at Month 1, 3, 6, 12, 18 and 24, and over the 24*month follow-up period - Percentage of radiological responders at Month 6, 12, 18 and 24, and over the 24*month follow-up period - Absolute change from baseline in WOMAC® VA3.1 total score and composite pain, stiffness, and function subscales scores - Time to hip fracture - Time to hip arthroplasty - Percentage of patients requiring hip arthroplasty

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)