Carbon fibre reinforced PEEK versus conventional prophylactic internal fixation in patients with low grade chondrosarcoma

Carbon fibre reinforced PEEK versus conventional prophylactic internal fixation in patients with low grade chondrosarcoma - CFR-PEEK

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45703

Enrollment

Registered

2017-05-03

Start date

2017-08-30

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Chondrosarcoma/ low grade bone tumour

Interventions

Distal femoral prophylactic plate osteosynthesis with a Carbon Fibre Reinforced PolyEtherEtherKetone distal femoral plate (CFR-PEEK, Carbofix).

Carbon

CFR-PEEK

Chondrosarcoma

Osteosynthesis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) Males and females, 18 years of age or older 2) Primary treatment of an ACT/chondrosarcoma grade 1 with curettage 3) Adjuvant treatment with phenolysation or cryotherapy 4) Indication for prophylactic osteosynthesis

Exclusion criteria

Exclusion criteria: 1) Primary pathologic fracture 2) Re-excision of an ACT/chondrosarcoma grade 1 3) Defect reaching into knee joint 4) Treatment with knee arthroplasty 5) Likely problems, in the judgement of the investigator, with maintaining follow up

Design outcomes

Primary

Measure	Time frame
Primary study parameter is the influence of field inhomogeneity on visualisation of anatomical structures of importance. A scoring system similar to the scoring systems of Zimel will be used (see attached publication). Excochleation borders on MRI will be scored using a 5 point scoring system. Visualisation will be graded with percentage of the excochleation borders visual on MRI as follows: 1=0-20%, 2=20-40%, 3=40-60%, 4=60-80%, 5=80-100%. A subjective scoring system is composed to reflect the degree of certainty that recurrence of tumour is absent to the observer (musculoskeletal radiologist/ oncologic orthopaedic surgeon). Grading will be as follows: 1= completely uncertain, 2=uncertain, 3=some degree of certainty, 4=certain, 5= definite. Sequences used to score the MR images are; T1, T2, T1 gadolinium and T2 fat suppression. All sagittal and transversal coupes will be used for evaluation. In addition total field inhomogeneity volume will be calculated.	—

Measure

Time frame

Primary study parameter is the influence of field inhomogeneity on visualisation of anatomical structures of importance. A scoring system similar to the scoring systems of Zimel will be used (see attached publication). Excochleation borders on MRI will be scored using a 5 point scoring system. Visualisation will be graded with percentage of the excochleation borders visual on MRI as follows: 1=0-20%, 2=20-40%, 3=40-60%, 4=60-80%, 5=80-100%. A subjective scoring system is composed to reflect the degree of certainty that recurrence of tumour is absent to the observer (musculoskeletal radiologist/ oncologic orthopaedic surgeon). Grading will be as follows: 1= completely uncertain, 2=uncertain, 3=some degree of certainty, 4=certain, 5= definite. Sequences used to score the MR images are; T1, T2, T1 gadolinium and T2 fat suppression. All sagittal and transversal coupes will be used for evaluation. In addition total field inhomogeneity volume will be calculated.

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Secondary

Measure	Time frame
-	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)