Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation

NCT06093763 | Unknown DMC

• 1 other identifier: NL68126.068.18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION A variety of bone grafts and substitutes are available for filling bone defects in the distal radius after corrective osteotomy, but the harvesting of bone from the iliac crest is the gold standard as it allows easy access to corticocancellous bone of a desirable quality and quantity. The idea behind bone grafting is to provide optimal bone formation and structural stability, which is crucial for bone healing. However, the harvesting and use of bone from the iliac crest potentially comes with the risk of complications such as delayed union of the osteotomy defect; size mismatch between the graft and the osteotomy defect; longer operation time; donor site morbidity including nerve, arterial, and ureteral injury; herniation of abdominal contents; sacroiliac joint instability; pelvic fractures; hematoma and infection. As these disadvantages of bone grafting can have a major impact on patients' everyday lives, research is needed on whether bone grafting is genuinely necessary during corrective osteotomy and plate fixation of the distal radius OBJECTIVE The objective of this study is to investigate whether harvested bone graft from the iliac crest necessary is during corrective osteotomy and plate fixation in patients with malunited distal radius fractures. STUDY DESIGN This is a prospective, randomized, controlled multicenter study. Patients will undergo the following examinations once before the operation and five times afterwards: 1) the patients will fill out three questionnaires, 2) complications will be noted, 3) the wrist function will be measured, and 4) radiographs/CT scans will be made. STUDY POPULATION All patients over the age of 18 years who have a symptomatic malunion after distal radius fracture and are eligible for surgical correction. INTERVENTION Surgical correction in the form of open wedge corrective osteotomy and plate fixation without bone grafting. USUAL CARE Open wedge corrective osteotomy and plate fixation with harvesting bone from the iliac crest. OUTCOME MEASURES Primary outcomes: complications and quality of life. Secondary outcomes: time to complete bone healing, functional outcomes, and cost effectiveness.

Conditions

Malunion of Fracture of Radius

Keywords

open wedge osteotomy; bone grafting; time of bone healing; complications; Quality of life; Subjective and objective functional outcomes; Cost effectiveness

Outcome Measures

Primary Outcomes (3)

• Complications

  number and severity during and after the operation

  follow-up period of at least one year

• Quality of life using the EQ-5D-5L questionnaire

  EQ-5D-5L questionnaire

  follow-up period of one year

• Time to complete bone healing

  Bone healing will be considered complete when the osteotomy gap is filled with bone formation.

  follow-up period of one year

Secondary Outcomes (4)

• Subjective functional outcomes

  follow-up period of one year

• Subjective functional outcome

  follow-up period of one year

• Objective functional outcomes

  follow-up period of one year

• Cost effectiveness

  follow-up period of at least one year

Study Arms (2)

Patients with symptomatic malunion of distal radius receiving bone grafting

ACTIVE COMPARATOR

Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.

Procedure: Group with bone grafting

Patients with symptomatic malunion of distal radius receiving none bone grafts

ACTIVE COMPARATOR

Open wedge corrective osteotomy and plate fixation without harvesting and using bone from the iliac crest.

Procedure: Group without bone grafting

Interventions

Group without bone grafting PROCEDURE

Open wedge corrective osteotomy and plate fixation without bone grafting.

Patients with symptomatic malunion of distal radius receiving none bone grafts

Group with bone grafting PROCEDURE

Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.

Patients with symptomatic malunion of distal radius receiving bone grafting

Eligibility Criteria

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

You may qualify if:

• Patients of either sex over the age of 18 years
• Symptomatic malunion of the distal radius
• Eligible for open wedge osteotomy and plate fixation with or without bone grafting from iliac crest.
• Patients are able to undergo postoperative follow-up of at least 12 months.

You may not qualify if:

• Patients who are pregnant
• Patients who have known systemic or metabolic disorders leading to progressive bone deterioration
• Patients who take chronic use of glucocorticoids.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Haga Hospital: collaborator
• Amsterdam UMC: collaborator
• VieCuri Medical Centre: collaborator
• Zuyderland Medical Centre: collaborator
• Elkerliek Hospital: collaborator
• Erasmus Medical Center: collaborator
• Amphia Hospital: collaborator
• Reinier Haga Orthopedisch Centrum: collaborator
• Flevoziekenhuis: collaborator
• Diakonessenhuis, Utrecht: collaborator
• Xpert Clinics: collaborator

Study Sites (1)

MaastrichtUMC

Maastricht, Zuid-Limburg, 6229 HX, Netherlands

RECRUITING

MeSH Terms

Interventions

Population Groups; Bone Transplantation

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Pascal Hannemann, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Disseldorp, MD

CONTACT

0031433877489; dominique.disseldorp@mumc.nl

Fabienne Hameleers

CONTACT

0031433877489; f.hameleers@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A web based randomisation tool will used for randomization according to the GCP-guidelines. Prestratification per hospital will be performed. Patients and the treating surgeon cannot be blinded for the treatment because a part of these patients will undergo bone grafting derived from the iliac crest. The statistician will be blinded for the treatment. 6.3 Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All included patients will undergo an open wedge osteotomy and plate fixation according to the standard surgical techniques. In one group, the bone defect will be filled with bone graft of the iliac crest after open wedge osteotomy according the standard procedure. The other group includes patients who will not receive any bone grafts. The participating hospitals have extensive experience with both treatments.

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 23, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: June 11, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)