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

NCT ID: NCT07207447

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2024-08-10

Brief Summary

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.

Detailed 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.

Conditions

Fracture Non Union

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NUSS group 1

Group Type: ACTIVE_COMPARATOR

Improving the stability and re-fixation with different modalities

Intervention Type: 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.

NUSS group 2

Group Type: ACTIVE_COMPARATOR

Re-fixation with biological stimulation

Intervention Type: 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.

NUSS group 3

Group Type: ACTIVE_COMPARATOR

complex care with non-union resection and bone reconstruction

Intervention Type: 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.

NUSS group 4

Group Type: ACTIVE_COMPARATOR

Amputation

Intervention Type: PROCEDURE

Amputation with consideration of prosthesis.

Interventions

Improving the stability and re-fixation with different modalities

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.

Intervention Type: PROCEDURE

Re-fixation with biological stimulation

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.

Intervention Type: PROCEDURE

complex care with non-union resection and bone reconstruction

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.

Intervention Type: PROCEDURE

Amputation

Amputation with consideration of prosthesis.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain Shams University

Cairo, Abbasia, Egypt

Countries

Egypt

Other Identifiers

FMASU MD21/2022

Identifier Type: -

Identifier Source: org_study_id