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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01524965 on ClinicalTrials.gov