Allograft reconstruction of the extensor mechanism after resection of soft tissue sarcoma

Completed

• Conditions: Soft tissue tumors around the knee joint; Musculoskeletal Diseases

• Registration Number: ISRCTN63060594
• Lead Sponsor: Balgrist University Hospital

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29951320

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-12-31
• Study Start: 2017-12-04
• Last Update Posted: 16 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Patients who have undergone a surgical resection of a soft tissue sarcoma affecting the quadriceps tendon, the patella and / or the patellar tendon without apparent joint involvement
2. Patients ranged from 34 to 68 years

Exclusion Criteria

Patients with involvement of the joint space needed an extra-articular knee resection and an allograft prosthetic composite reconstruction.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Knee function the active range of motion, active flexion and extension lag is measured using the International Society of Limb Salvage (ISOLS) score at yearly follow ups and using data from reviewing the patient charts.<br>2. Local recurrence rate is measured using Kaplan Meier curve for local recurrence free survival for 10 years. The presence of a local recurrence was detected by careful clinical examination and radiologic controls.<br>3. Surgical complication rate is measured by registering all the revision surgeries of the included patients during the observational time.

Secondary Outcome Measures

Name	Time	Method
1. Metastatic disease survival is measured using Kaplan Meier curve for metastasis free survival for 10 years. The presence of a metastasis was detected by careful clinical examination and CT chest.<br>2. Overall disease specific survival is measured using Kaplan Meier curve for overall survival for 10 years.<br>3. Functional outcome is measured by measuring the active range of motion (°), active flexion and extension lag at the last follow up. The International Society of Limb Salvage (ISOLS) score was calculated at the last follow up.