Core Decompression With or Without Cement Packing for ONFH

NCT04233125 | Completed Phase 1

• 1 other identifier: 9604M11032
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

Osteonecrosis of the femoral head (ONFH) is difficult to treat as collapse frequently occurs after core decompression (CD). This may be due to the failure to provide structural support during revascularization and healing. Reports of polymethylmethacrylate (PMMA) packing of the femoral head after CD for ONFH have noted favorable results. This study was undertaken to determine whether the addition of PMMA packing to CD provides any benefit to progression-free survival (PFS) and conversion to total hip arthroplasty-free survival (CFS). Secondary objectives were to assess for differences in functional outcomes and predictive factors for progression of the disease.

Conditions

Osteonecrosis

Keywords

Femoral Head; Hip; Core Decompression; Polymethlymethacrylate; Cement; Progression; Survival

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression Free Survival (PFS) is defined as the length of time (reported in months) following surgery that participants have no signs of radiographic progression of femoral head osteonecrosis. Radiographic progression is defined as any degree of flattening or loss of spherical contour of the femoral head as detected on the radiographs or MRI. Appearance of a subchondral fracture (crescent sign) on radiographs or MRI was also considered a sign of progression.

  5 years

Secondary Outcomes (7)

• Conversion Free Survival (CFS)

  5 years

• Mean Harris Hip Score (HHS)

  baseline, 2 years post surgery, 5 years post surgery

• Change in Harris Hip Score (HHS)

  baseline, 2 years post surgery

• Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  baseline, 2 years post surgery, 5 years post surgery

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  baseline, 2 years post surgery

Study Arms (2)

Core Decompression (CD) Only

ACTIVE COMPARATOR

Participants in this group receive standard care

Procedure: Core Decompression

Added Polymethylmethacrylate (PMMA)

EXPERIMENTAL

Participants in this group receive standard care with an additional treatment

Procedure: Core Decompression; Procedure: PMMA augmentation

Interventions

Core Decompression PROCEDURE

Core Decompression

Added Polymethylmethacrylate (PMMA); Core Decompression (CD) Only

PMMA augmentation PROCEDURE

Polymethylmethacrylate (PMMA) augmentation

Added Polymethylmethacrylate (PMMA)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Association Research Circulation Osseous (ARCO) Stage I and II ONFH diagnosed using MRI and radiographic imaging

You may not qualify if:

• pre-existing collapse, subchondral fracture or degenerative changes of the hip

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Osteonecrosis; Disease Progression

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: January 1, 1997
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2008
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share