Clinical Trials Directory

Trials / Terminated

TerminatedNCT01524965

The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus

The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
94 (actual)
Sponsor
University of Helsinki · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREImmediate mobilisation after locking-plate osteosynthesisImmediate 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.
PROCEDUREStandard mobilisation after locking plate osteosynthesisImmediately 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.
DEVICEOsteosynthesis 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.

Timeline

Start date
2011-05-01
Primary completion
2023-10-11
Completion
2023-10-21
First posted
2012-02-02
Last updated
2025-01-07

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT01524965. Inclusion in this directory is not an endorsement.