Health TrialsbyHealthPanel

Weight-bearing of Surgically Treated Acetabular Fractures.

ConditionAcetabular Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorHospital District of Helsinki and Uusimaa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Open reduction and internal fixation (ORIF)

    Procedure/Surgery

    Approaches used: * Intrapelvic approach +/- iliac window * Kocher-Langenbeck approach

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Weight-bearing as toleratedExperimental treatment 1 intervention
Group B: Touch-down weight-bearingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

mHHS

Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome

Time frame
1 year
2

NRS

Pain during gate, Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain

Time frame
1 year

Secondary outcomes

1

mHHS

Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome

Time frame
0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years
2

NRS

Pain at rest and during gate (2 scores), Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain

Time frame
0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years
3

WOMAC

Western Ontario and McMaster Universities Osteoarthritis Index, Scale 0-96, higher scores mean better outcome

Time frame
0 weeks, 1 year, 2 years, 5 years, 10 years
4

RAND36

Patient reported quality of life, Scale 0-100, higher scores mean better outcome

Time frame
0 weeks, 1 Year, 2 years, 5 years, 10 years

Other outcomes

1

Complications

Any complications during treatment are documented

Time frame
At any point of time during treatment
2

Total hip replacement

Conversion to total hip replacement

Time frame
During 10 years postoperatively
3

Reduction of the articular surface after surgery

The reduction is assessed with a postoperative CT scan

Time frame
Postoperatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital District of Helsinki and Uusimaa

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: