Application of LARS Ligament in Bone Prosthesis Replacement

NCT05616182 | Not Yet Recruiting

• 1 other identifier: ZZUSC-17
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Tumor

Outcome Measures

Primary Outcomes (2)

• Postoperative complications

  Complications of patients undergoing LARS ligament and bone prosthesis replacement.

  From surgery to 24 months after surgery

• 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

Study Arms (1)

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.

Other: LARS ligament and bone prosthesis replacement was performed

Interventions

LARS ligament and bone prosthesis replacement was performed OTHER

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

LARS ligament and bone prosthesis replacement was performed

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing LARS ligament and bone prosthesis replacement

You may qualify if:

• 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.

You may not qualify if:

• Not Applicable.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Department of Bone and Soft Tissue ,Henan Cancer Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 15, 2022
• Study Start: December 30, 2024
• Primary Completion (Estimated): February 28, 2032
• Study Completion (Estimated): February 28, 2032
• Last Updated: January 24, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)