The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus
NCT01524965 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94
Last updated 2025-01-07
Summary
Open reduction and locking plate osteosynthesis is a commonly used and well-accepted treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff despite intensive rehabilitation, limiting the function of the upper extremity and decreasing the quality of life. The accepted postoperative mobilisation protocol includes passive exercises until six weeks postoperatively and active range of motion exercises after that. There is good evidence that conservatively treated fractures of the same site heal better and faster if mobilised immediately. The study compares "standard mobilisation" versus "immmediate mobilisation" in a prospective, randomized, controlled trial in order to find the optimal time-frame for physiotherapy to produce best possible results. Outcome measures are assessed at specific time points after the operation and comparisons between groups are made to follow the rate of recovery and end results.
Conditions
- Humeral Fracture
Interventions
- PROCEDURE
-
Immediate mobilisation after locking-plate osteosynthesis
Immediate passive range of motion exercises are begun postoperatively, after 3 weeks, active unloaded mobilisation begins after three weeks and active, loaded use is allowed 6 weeks postoperatively. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.
- PROCEDURE
-
Standard mobilisation after locking plate osteosynthesis
Immediately postoperatively the arm is held in a sling, active mobilisation of healthy joints and pendel exercises are befun. Passive range of motion exercises of the shoulder are begun 3 weeks postoperatively. Active mobilisation begins after six weeks. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.
- DEVICE
-
Osteosynthesis with a locking plate (Philos)
Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management.
Sponsors & Collaborators
-
Finnish Institute for Health and Welfare
collaborator OTHER_GOV -
University of Helsinki
lead OTHER
Principal Investigators
-
Tuomas Lähdeoja, MD · Helsinki University Central Hospital
-
Mika Paavola, MD, PhD · Helsinki University Central Hospital
-
Jarkko Pajarinen, MD, PhD · Helsinki University Central Hospital
-
Seppo Koskinen · Helsinki University Central Hospital
-
Antti Malmivaara, MD, PhD · Finnish Institute for Health and Welfare
-
Reijo Sund, MD, PhD · Finnish Institute for Health and Welfare
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-05-31
- Primary Completion
- 2023-10-11
- Completion
- 2023-10-21
Countries
- Finland
Study Locations
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