Intra-articular Knee Fractures Clinical Trial
Official title:
Use of Continuous Passive Motion in the Post-Operative Treatment of Intra-articular Knee Fractures
| Verified date | March 2013 |
| Source | Greenville Health System |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
Decreased range of motion is common after fractures around the knee and can impact a patient's ability to perform activities of daily living such as rising from a seated position or getting in and out of a bathtub. A continuous passive motion (CPM) machine is a machine that continuously moves a joint (such as the knee) without the patient having to use the muscles in his/her leg. A goal of this therapy is to maintain as much motion as possible following this injury. This study is a randomized, prospective study to evaluate the effectiveness of CPM in maintaining knee range of motion following open reduction and internal fixation (ORIF) of fractures around the knee
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - If the patient has an intra-articular distal femur or proximal tibia fracture - Independent ambulatory prior to injury - No previous knee injury limiting motion Exclusion Criteria: - If the patients range of motion was decreased prior to injury (ex. Osteoarthritis, previous knee fracture or injury) - Any contraindication to CPM (concomitant hip or ankle fracture) - Open physis of tibia or distal femur - Pathological Fracture - Compartment Syndrome - Neurovascular injury - Fracture due to gunshot wound - Greater than 21 days from fracture to definitive open reduction and internal fixation - Fractures treated with definitive external fixation - Open fractures - Extensor mechanism injuries - Likely problems in the judgment of the investigator with maintaining follow-up |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Greenville Hospital System Univeristy Medical Center | Greenville | South Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Greenville Health System | Orthopaedic Trauma Association |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Knee Range of Motion | 48 hours, 2 weeks, 6 weeks, 3 months, 6 months and 1 year | No |