TerminatedNot Applicable

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

Stopped: Recruitment decline due to change in clinical practice to less surgery for the fractures of interest

Finland94 participantsStarted 2011-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older * Surgery can be performed within 10 days of injury * A dislocated (\>1cm or 35 degrees) AO 11-A2, -A3, -B1 or -B2 fracture of the surgical neck of the proximal humerus with a possible fracture of the Tuberculum Majus Exclusion Criteria: * Glenohumeral dislocation * Fracture of the Tuberculum Minus * Open fracture * Additional fractures in the shoulder region * Other injuries requiring surgical treatment * Clinically significant injury of the brachial plexus or vasculature * Pathological fracture associated with cancer * History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc) * Rheumatoid Arthritis in the shoulder requiring active treatment * Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc) * Unwillingness to accept some of the treatment options.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disablities of Arm, Hand and Shoulder

Timeframe: 3 weeks

Disablities of Arm, Hand and Shoulder

Timeframe: 6 weeks

Disablities of Arm, Hand and Shoulder

Timeframe: 3 months

Disablities of Arm, Hand and Shoulder

Timeframe: 6 months

Disablities of Arm, Hand and Shoulder

Timeframe: 1 year

Disablities of Arm, Hand and Shoulder

Timeframe: 2 years

Trial details

NCT IDNCT01524965

SponsorUniversity of Helsinki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-11

View on ClinicalTrials.gov More Humeral Fracture trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Disablities of Arm, Hand and Shoulder

Timeframe: 3 weeks

Disablities of Arm, Hand and Shoulder

Timeframe: 6 weeks

Disablities of Arm, Hand and Shoulder

Timeframe: 3 months

Disablities of Arm, Hand and Shoulder

Timeframe: 6 months

Disablities of Arm, Hand and Shoulder

Timeframe: 1 year

Disablities of Arm, Hand and Shoulder

Timeframe: 2 years