Clinical safety and efficacy evaluation of mineralized collagen combined with polymethyl methacrylate bone cement in multi clinical center

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300077711

Enrollment

Unknown

Registered

2023-11-16

Start date

2023-06-05

Completion date

Unknown

Last updated

2023-11-21

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

Conditions

knee osteoarthritis/vertebral compression fracture

Interventions

Experiment group in TKA:Adding mineralized collagen in bone cement during TKA

Control group in TKA:Using primary bone cement during TKA

Experiment group in PVP:Use of bone cement with added mineralized bone collagen in PVP surgery

Control group in PVP:Using primary bone cement in PVP surgery

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Hospitalized patients aged = 50 and = 70, regardless of gender; (2) Preoperative diagnosis of end-stage osteoarthritis; (3) Strong willingness to undergo unilateral total knee arthroplasty. / (1) Hospitalized patients aged = 40 and = 70, regardless of gender; (2) Patients diagnosed with osteoporotic vertebral fractures before surgery; (3) Fresh vertebral fracture, MRI indicates high signal in the compression phase.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of allergies to any active ingredient or excipient in mineralized collagen modified PMMA bone cement; (2) Patients with local infection or potential infection focus; (3) Patients with knee joint diseases caused by autoimmune diseases such as rheumatoid arthritis and ankylosing spondylitis; (4) Patients with severe flexion and inversion deformities who require the use of special prostheses / (1) Patients with a history of allergies to any active ingredient or excipient in mineralized collagen modified PMMA bone cement; (2) Patients with local infection or potential infection focus; (3) Preoperative damage to the posterior wall of the vertebral body may lead to bone cement leakage in patients; (4) Violent vertebral fracture.

Design outcomes

Primary

Measure	Time frame
vertebral height ;angle of vertebral;KSS;radiolucent line ;implant loosening ;HSS score;Bone cement injection time;Amount of intraoperative bone cement injection;Leakage of bone cement;Adjacent vertebral re-fracture rate;ROM;	—

Secondary

Measure	Time frame
CRP;VAS score;hemoglobin;Lower limb force line;Bone cement thickness;	—

Countries

China

Contacts

Public ContactXisheng Weng

Peking Union Medical College Hospital

xshweng@medmail.com.cn+86 133 6620 0018

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026