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

NCT07207447 | Completed

• 1 other identifier: FMASU MD21/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture Non Union

Keywords

NUSS; Non-union Scoring System; Fracture Non-Union; Bone defect

Outcome Measures

Primary Outcomes (2)

• Radiological Fracture Union

  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.

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

• Clinical Fracture Union

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

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

Study Arms (4)

NUSS group 1

ACTIVE COMPARATOR

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

NUSS group 2

ACTIVE COMPARATOR

Procedure: Re-fixation with biological stimulation

NUSS group 3

ACTIVE COMPARATOR

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

NUSS group 4

ACTIVE COMPARATOR

Procedure: Amputation

Interventions

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.

NUSS group 1

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.

NUSS group 2

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.

NUSS group 3

Amputation PROCEDURE

Amputation with consideration of prosthesis.

NUSS group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, 11566, Egypt

Location

MeSH Terms

Conditions

Fractures, Ununited

Interventions

Amputation, Surgical

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 6, 2025
• Study Start: February 10, 2022
• Primary Completion: July 10, 2024
• Study Completion: August 10, 2024
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

EG (1)