Validity of the Non-union Scoring System in Management of Long Bone Fracture Non-union

Ain Shams University

Status: Completed

Conditions: Fracture Non Union

Treatments: Procedure: Re-fixation with biological stimulation; Procedure: complex care with non-union resection and bone reconstruction; Procedure: Amputation; Procedure: Improving the stability and re-fixation with different modalities

Study type: Interventional

Funder types: Other

Identifiers

NCT07207447

FMASU MD21/2022

Details and patient eligibility

About

The aim of this study is to apply Calori Non union Scoring System on long bone non-union cases and evaluate the results of treatment o f the patients according to the score.

Full description

The aim of this study is to apply Calori Non union Scoring System on long bone non-union cases and evaluate the results of treatment o f the patients according to the score. The study will be on patients with lower limb long bone diaphyseal fracture non-union. All patients will be assessed preoperatively by Clinical Evaluation: History, general examination, local examination, radiological evaluation: Plain X-ray films showing joint above and joint below the non-union site, laboratory Investigations: CBC, ESR, CRP and HbA1c. For patient allocation, patients will be divided into four groups according to the NUSS score, with group one (0-25 points) who underwent improving the stability and re-fixation with different modalities such as exchange plate with longer plate, intramedullary nailing, exchange nailing with larger diameter, plating over nail or dynamization of intramedullary nail. Group two (26-50 points) underwent re-fixation in addition to biological stimulation such as bone grafting, either with plate and bone graft, plate over nail and graft, or with external fixation with LRS or Ilizarov and grafting in one stage or two stages. Group three (51-75 points) required more complex care with resection of the non-union and dealing with the defect with bone transport, either direct transport or staged with cement spacer and later bone transport, Masquelet technique or acute compression and lengthening with another osteotomy. Group four (76-100 points) underwent amputation with consideration of prosthesis. The patients will be followed up at regular intervals as regard radiological and clinical evaluation until full union is achieved or non-union is established. The assessment includes; clinical and functional assessment based on pain at the fracture site and recovery of the usual activities or work, and radiological assessment based on plain radiograph x-rays, CT scan if needed to assess union. Radiological union is considered based on the presence of bridging callus (3/4 of cortices) in both anteroposterior and lateral views.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sex: both sexes.
• Age: Above 18 years old.
• Lesion: Tibial or femoral bone non-union.

Exclusion criteria

• Skeletal immaturity.
• Any immunosuppressive drug therapy.
• Autoimmune disease.
• Neoplasia.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

NUSS group 1

Active Comparator group

Treatment:

Procedure: Improving the stability and re-fixation with different modalities

NUSS group 2

Active Comparator group

Treatment:

Procedure: Re-fixation with biological stimulation

NUSS group 3

Active Comparator group

Treatment:

Procedure: complex care with non-union resection and bone reconstruction

NUSS group 4

Active Comparator group

Treatment:

Procedure: Amputation