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Completed

NCT Number: NCT07207447

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Abbasia, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Improving the stability and re-fixation with different modalities

Procedure

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.

Re-fixation with biological stimulation

Procedure

Re-fixation with 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.

complex care with non-union resection and bone reconstruction

Procedure

complex care with non-union resection and bone reconstruction, including 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.

Amputation

Procedure

Amputation with consideration of prosthesis.

Primary outcomes

  1. Radiological Fracture Union

    Time frame: According to each group ranging from 5 months in group 1, 7 in group 2 and up to 12 months in group 3

    Radiological fracture union is considered based on the presence of bridging callus (3/4 of cortices) in both anteroposterior and lateral views in x rays.

  2. Clinical Fracture Union

    Time frame: According to each group ranging from 4 months in group 1, 6 in group 2 and up to 11 months in group 3.

    Clinical fracture union assessment is based on presence or absence of pain at the fracture site.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Validity of the Non-union Scoring System in Management of Long Bone Fracture Non-union: A Prospective Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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