Application of LARS Ligament in Bone Prosthesis Replacement

Malignant Tumor Clinical Trial

Official title:

A Prospective, Real-world, Single-center, Cohort Study of LARS Ligaments in Bone Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05616182
• Other study ID #: ZZUSC-17
• Status: Not yet recruiting
• Start date: December 30, 2024
• Est. completion date: February 28, 2032

Study information

• Verified date: August 2023
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a single-center, prospective, real-world observational study designed to enroll all patients eligible for enrollment. Basic data, treatment methods, postoperative complications and limb function were collected. The differences in postoperative complications, postoperative limb function and so on between patients who underwent LARS ligament implantation and bone prosthesis replacement (ligament group) and patients who underwent bone prosthesis replacement (control group) were compared.

Description:

This is a single-center prospective real-world observational study of 100 eligible patients with bone tumors who are scheduled to undergo LARS ligament implantation and/or bone prosthesis replacement in Henan Cancer Hospital in the next 10 years. Basic data, treatment methods, postoperative complications and limb function were collected. The differences in postoperative complications, postoperative limb function and so on between patients who underwent LARS ligament implantation and bone prosthesis replacement (ligament group) and patients who underwent bone prosthesis replacement (control group) were compared.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 28, 2032
• Est. primary completion date: February 28, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Men and women of all ages are welcome.

Pathologically confirmed in our hospital as a subtype of malignant tumor.

He received LARS ligament and bone prosthesis replacement at our hospital.

Exclusion Criteria:

Not Applicable.

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

Other:
• LARS ligament and bone prosthesis replacement was performed
To report the postoperative complications and limb function of patients who underwent LARS ligament and bone prosthesis replacement in Henan Cancer Hospital.

Locations

Country	Name	City	State
China	Department of Bone and Soft Tissue ,Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Complications of patients undergoing LARS ligament and bone prosthesis replacement.	From surgery to 24 months after surgery
Primary	Limb function	Limb function was assessed using the Musculoskeletal Oncology Society (MSTS) scoring scale for seven items, namely movement, pain, stability, deformity, strength, functional activity, and emotional receptiveness. The highest possible score is 35, with 5 points allocated to each project.	Patients were enrolled until 24 months after surgery