Health Condition 1: R978- Other abnormal tumor markers Health Condition 2: R978- Other abnormal tumor markers Health Condition 3: null- Patients with primary malignant bone tumors around the knee. Patients with non metastatic disease. Tumor should be amenable to resection with adequate margins.
Conditions
Interventions
Intervention1: TKP2.4: A prosthesis is being studied for itâ??s function and durability. Prosthesis will be evaluated for Implant Survival at 2 yr follow up with appropriate intermittent follow up. Ot
Sponsors
Non Ferrous Materials Technology Development Centre
All India Institute of Medical Sciences AIIMS
Government Medical College Chandigarh
Hamdard Institute of Medical Sciences and Research Jamia Hamdard Campus New Delhi
Office of the Principal Scientific Adviser to the Government of India
PD Hinduja Hospital and Medical Research Centre Mumbai
Tata Memorial Hospital Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with primary malignant bone tumors around the knee 2. Patients with non metastatic disease. 3. Tumor should be amenable to resection with adequate margins 4. It is possible to retain adequate limb function after resection and reconstruction 5. Expected ultimate function is superior to that after ablative surgery 6. Patient is undergoing appropriate neo-adjuvant therapy 7. Informed consent from patient or parents as appropriate
Exclusion criteria
Exclusion criteria: 1. Patients with metastatic disease 2. Tumor not amenable to resection with adequate margins 3. Expected ultimate function after ablative surgery is superior to that with limb salvage 4. Patient not undergoing appropriate adjuvant therapy 5. Patient unwilling to participate in the trial with new implant 6. Patient unwilling or unreliable to follow up regularly as per trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Prosthesis durability 2. Function score as measured by the MSTS score Timepoint: 2 yrs follow up & as per CRF details | — |
Secondary
| Measure | Time frame |
|---|---|
| Ease of use of implant and instrumentation as asessed by the surgeonTimepoint: 2 yrs follow up & as per CRF details | — |
Countries
India
Contacts
Public ContactDr K Balasubramanian
P.D. Hinduja Hospital and Medical Research Centre, Mumbai
Outcome results
None listed