Weight-bearing of Surgically Treated Acetabular Fractures.

Acetabular Fracture Clinical Trial

Official title:

Weight-bearing of Surgically Treated Acetabular Fractures. A Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04724811
• Other study ID #: HUS/234/2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Hospital District of Helsinki and Uusimaa
• Contact: Kristian Seppänen, MD
• Phone: 094711
• Email: kristian.seppanen[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. The study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively.

Both study groups are stratified according to

• Type of fracture (anterior approach vs anterior + additional posterior approach)

• Dislocated dome vs non-dislocated/ non existing separate dome fragment

Patients, who are eligible to participate in the trial but choose not to participate in randomisation are asked to enrol in a prospective cohort follow-up cohort. This is to examine a potential participation bias in the RCT groups. These patients will not be counted into the target amount of 50 RCT patients.

Description:

For the past 20 years, the established treatment of dislocated acetabular fractures has been surgical reduction and stable osteosynthesis. Good long-term results have been reported in these patients. At present, the mobilisation of these patients after surgery is generally restricted for several weeks ranging from 6-12 weeks touch-down- or non-weight-bearing with no uniform protocol. However there is no scientific evidence for limiting post operative weight-bearing. Accordingly the need of studies on weight-bearing surrounding periarticular fractures has been advocated.

Acetabular fractures in the elderly population are becoming more common and pose significant challenges for treatment including postoperative rehabilitation. Our aim is to investigate if patients benefit of a more liberal weight-bearing regime postoperatively. The primary outcome is measured at 1 year, secondary outcomes are followed up to 10 years postoperatively

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Unilateral dislocated acetabulum fracture (displacement of over 2mm in preoperative CT scan)

• The osteosynthesis is performed during 21 days after initial trauma

• The patient is willing to participate in the follow-up

Exclusion Criteria:

• Unwillingness to participate in randomisation

• Bilateral fracture

• Letournel & Judet type Both column or Posterior column and wall fractures

• Any other injury that prevents the patient from partial weight bearing

• Open fracture of the acetabulum

• Pathologic fracture (fragility fractures are not an exclusion criteria)

• Prior functional disability in the pelvis or lower extremity

• Non-Compliance due to dementia or other mental disability

• Prior daily pain medication due to hip-pain

• Unwillingness to accept one of the two mobilisation protocols

• Prior hip replacement on injured side

• BMI > 40

Related Conditions & MeSH terms

• Acetabular Fracture
• Fractures, Bone

Intervention

Procedure:
• Open reduction and internal fixation (ORIF)
Approaches used: Intrapelvic approach +/- iliac window Kocher-Langenbeck approach

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Hospital District of Helsinki and Uusimaa

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Any complications during treatment are documented	At any point of time during treatment
Other	Total hip replacement	Conversion to total hip replacement	During 10 years postoperatively
Other	Reduction of the articular surface after surgery	The reduction is assessed with a postoperative CT scan	Postoperatively
Primary	mHHS	Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome	1 year
Primary	NRS	Pain during gate, Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain	1 year
Secondary	mHHS	Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome	0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years
Secondary	NRS	Pain at rest and during gate (2 scores), Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain	0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years
Secondary	WOMAC	Western Ontario and McMaster Universities Osteoarthritis Index, Scale 0-96, higher scores mean better outcome	0 weeks, 1 year, 2 years, 5 years, 10 years
Secondary	RAND36	Patient reported quality of life, Scale 0-100, higher scores mean better outcome	0 weeks, 1 Year, 2 years, 5 years, 10 years