Fracture of Acetabulum Clinical Trial
Official title:
Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate
Verified date | February 2015 |
Source | Chinese PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
The purpose of this study is to determine whether this new anatomical locking plate is more effective and easy to operate than other plate in the treatment of acetabular posterior wall fracture.
Status | Completed |
Enrollment | 25 |
Est. completion date | February 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult men or women aged 18 years and older (with no upper age limit). - Fracture of the acetabular posterior wall fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI). - Operative treatment of fractures within 14 days of presenting to the emergency room. - Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker. - Anticipated medical optimalization for operation. - Provision of informed consent by patient or legal guardian. - No other major trauma. Exclusion Criteria: - Refuse to participate. - Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture). - Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture). - Retained hardware around the affected acetabular. - Infection around the acetabular (i.e., soft tissue or bone). - Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia). - Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors). - Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. - Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Orthopedics department; The General Hospital of the People's Liberation Army | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peifu Tang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone healing condition | Bone healing condition was checked by radiological examination. | six months | Yes |
Secondary | Rates of revision surgery | one year | Yes | |
Secondary | Patient quality of life | SF-36, ADL, FIM | one year | Yes |
Secondary | Complications | mortality, nonunion, implant breakage/failure, infection, DVT | one year | Yes |