Clinical trial NCT06093763: Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation
Official title: Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation in Patients With Malunited Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Haga Hospital
name: Amsterdam UMC
name: VieCuri Medical Centre
name: Zuyderland Medical Centre
name: Elkerliek Hospital
name: Erasmus Medical Center
name: Amphia Hospital
name: Reinier Haga Orthopedisch Centrum
name: Flevoziekenhuis
name: Diakonessenhuis, Utrecht
name: Xpert Clinics
First posted: 2023-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Complications
timeFrame: follow-up period of at least one year
measure: Quality of life using the EQ-5D-5L questionnaire
timeFrame: follow-up period of one year
measure: Time to complete bone healing
timeFrame: follow-up period of one year
Secondary outcomes:
measure: Subjective functional outcomes
timeFrame: follow-up period of one year
measure: Subjective functional outcome
timeFrame: follow-up period of one year
measure: Objective functional outcomes
timeFrame: follow-up period of one year
measure: Cost effectiveness
timeFrame: follow-up period of at least one year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MaastrichtUMC
state: Zuid-Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Pascal Hannemann, MD
role: PRINCIPAL_INVESTIGATOR
References: