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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
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight-bearing as tolerated | Experimental | Patients are instructed to mobilise the hip and weight-bear as tolerated |
|
| Touch-down weight-bearing | Active Comparator | Patients are instructed to mobilise the hip. Touch-down weight-bearing for 6-8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open reduction and internal fixation (ORIF) | Procedure | Approaches used:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| mHHS | Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome | 1 year |
| NRS | Pain during gate, Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| NRS | Pain at rest and during gate (2 scores), Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Any complications during treatment are documented | At any point of time during treatment |
| Total hip replacement | Conversion to total hip replacement |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristian Seppänen, MD | Contact | 094711 | kristian.seppanen@hus.fi | |
| Jan Lindahl, MD, PhD | Contact | 094711 | jan.lindahl@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Jan Lindahl, MD, PhD | Helsinki University Central Hospital | Study Chair |
| Kristian Seppänen, MD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Uusimaa | 00029 HUS | Finland |
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| ID | Term |
|---|---|
| D000070799 | Open Fracture Reduction |
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Prospective randomised non-inferiority study
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The surgeon is masked The investigator is masked
| 0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years |
| 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 |
| RAND36 | Patient reported quality of life, Scale 0-100, higher scores mean better outcome | 0 weeks, 1 Year, 2 years, 5 years, 10 years |
| During 10 years postoperatively |
| Reduction of the articular surface after surgery | The reduction is assessed with a postoperative CT scan | Postoperatively |