Results of Telescoping Nail In OI; a Case Series

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04694144
Collaborator
(none)
22
1
39
0.6

Study Details

Study Description

Brief Summary

Assess the postoperative functional outcomes after surgical correction of skeletal deformities of lower limbs in osteogenesis imperfecta patients as regard ambulation status, postoperative complications and reoperation rate.

Condition or Disease Intervention/Treatment Phase
  • Device: telescoping intramedullary nail

Detailed Description

Osteogenesis imperfecta (OI) is a rare heterogeneous group of inherited disorders characterized by brittle bones, frequent fractures, and skeletal deformities that affect an individual's ability to walk. Based on Sillence classification, there are four types of OI; Type I (mild, non-deforming), Type II (perinatal lethal), Type III (severely deforming), and Type IV (moderately deforming). Recently 3 types added type V, VI and type VII.

Deformities of the long bones are common in patients with osteogenesis imperfecta particularly in the lower limbs Where they are also more severe. Multiple fractures can occur and the ability to walk may be compromised.

The goal of orthopaedic surgery implies the correction of long bone bowing, rotational malalignment, angular deformity and prevention or reduction of the fracture incidence .Surgical intervention in the form of multiple osteotomies, realignment and fixation by intramedullary rods can correct deformity of the long bones and provides internal support enhancing the potential for standing and assisted or independent walking Sofield and Millar, Page and Mead popularized the operation of multiple osteotomies and fixation by intramedullary rods. In 1963 the baily dubow nail was first introduced The telescopic rodding and nailing have been developed in order to obtain a long lasting osteosynthesis in a growing long bone, thus, reducing the need of replacement. The evolution of telescoping rods for the treatment of fractures and deformity in children with diminished bone Quality has resulted in an approved and commercially available new single entry telescopic rod system, the Fassier Duval Telescopic IM System (FD-rod).

In recent publications a high reoperation rate for proximal rod migration and a complication rate up to 40% because of rod migration, limited telescoping and joint protrusion was found.

We hope that our study will advance the proper surgical intervention for children with osteogenesis imperfecta for better functional outcomes

Study Design

Study Type:
Observational
Anticipated Enrollment :
22 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Results of Telescoping Nail in. OI; A Case Series
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Ambulation status [All patients will be assessed clinically and radiologically for deformity 6 months after surgery.]

    the mobility status of each child will be allocated to one of the scores of the Gillette Functional Assessment Questionnaire Ambulation Scale and Hoffer and Bollock score

  2. Rod Complications [All patients will be assessed radiologically for evidence of rod complications within the first two years after surgery.]

    Radiographic evidence of rod problems including migration, bending, breakage, disengagement, jamming (failure of expansion/telescoping)

Secondary Outcome Measures

  1. Bone consolidation [All patients will be assessed clinically and radiologically one month after surgery.]

    patients will be assessed for the average time in weeks of consolidation at the osteotomy site(s)

  2. Timing of weight-bearing [All patients will be assessed clinically within the first three months after surgery.]

    The average time in weeks until full weight bearing

  3. Refracture [All patients will be assessed clinically and radiologically for refracture within the first two years after surgery.]

    The occurrence of a second fracture at the same long bone with the rod in place or in association with any rod complication

Other Outcome Measures

  1. Knee Range of Motion [All patients will be assessed clinically for knee range of motion 6 months after surgery.]

    The range within which the knee on the operated side can move in degrees

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age from 3-11 years

  • Severe lower limb deformity presented with or without fracture

Exclusion Criteria:
  • Nondisplaced/incomplete fractures in minimally deformed bones

  • Deformity angulation less than 20 degree

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Hospital AUH Assiut Egypt 71526

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Nariman Abol Oyoun, MD, Lecturer, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nariman Abol Oyoun, MD, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04694144
Other Study ID Numbers:
  • TIN in osteogenesis
First Posted:
Jan 5, 2021
Last Update Posted:
Sep 2, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2021