Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial
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ClinicalTrials.gov Identifier: NCT01719887 |
Recruitment Status :
Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : August 21, 2020
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Humeral shaft fractures represent 1-3% of all fractures and 20% of the humeral fractures. These fractures have historically been treated mainly conservatively with good results. Recent development in fracture treatment and findings that certain fracture types are more prone to non-union and bracing-related functional problems of adjacent joints are somewhat common have caused increasing interest in treating these fractures surgically. Return to activities is also considered to be quicker among surgically treated patients.
The purpose of this study is to evaluate effectiveness and cost-effectiveness of surgical treatment of humeral shaft fractures. Patients with an unilateral humeral shaft fracture who are willing to participate in the study after informed consent are randomly assigned to two different treatment methods:
- Surgical treatment with an open reduction and internal fixation with a 4,5mm locking plate.
- Conservative treatment with functional bracing
The randomization is done using blocked randomization (block sizes are not known by the enrolling or assigning physician) and stratification is done according to fracture type (AO-OTA type A vs. type B/C) and radial nerve status (total/subtotal motor palsy vs. no palsy).
Standard follow-up visits at 6 weeks, 3, 6 and 12 months are arranged. Later follow-up visits are arranged at 2, 5 and 10 years for the study purpose. Patients fill evaluation forms and clinical and radiological assessments are made. The physiotherapist doing objective functional measurements is blinded to treatment method. Both study groups receive physiotherapy after the initial treatment.
Condition or disease | Intervention/treatment | Phase |
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Fracture | Device: Conservative treatment Procedure: Operative treatment Other: Physiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial. |
Actual Study Start Date : | November 4, 2012 |
Actual Primary Completion Date : | January 2019 |
Estimated Study Completion Date : | January 2028 |
Arm | Intervention/treatment |
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Active Comparator: Conservative treatment
Conservative treatment with functional brace and physiotherapy.
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Device: Conservative treatment
Conservative treatment with functional brace. Other: Physiotherapy Physiotherapy is arranged to both groups at 3 and 9 wks. |
Experimental: Operative treatment
Operative treatment with open reduction and internal fixation with 4,5mm locking compression plate. Physiotherapy at 3 and 9 wks.
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Procedure: Operative treatment
Operative treatment with open reduction and internal fixation using 4,5mm locking compression plate. Other: Physiotherapy Physiotherapy is arranged to both groups at 3 and 9 wks. |
- The Disabilities of the Arm, Shoulder and Hand Score (DASH) [ Time Frame: at 12 months ]
- Subjective assessment of the function of the upper extremity [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ]Numerical Rating Scale (NRS) 0-10
- Constant Score [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ]
- Elbow ROM [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ]
- Health-related quality of life (15D) [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ]
- Complications [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ]Incidence of complications (i.e. non-union, malunion, re-fracture, reoperation, infection and iatrogenic radial palsy) is recorded and compared between study groups.
- Cost-effectiveness [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ]Quality-adjusted life years/months measured as a change in 15D tool, pain-NRS and other outcome measures.
- Subjective assessment of the function of the upper extremity [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ]Likert Scale 1-7
- Subjective assessment of the function of the elbow [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ]Numerical Rating Scale (NRS) 0-10
- The Disabilities of the Arm, Shoulder and Hand Score (DASH) [ Time Frame: at 6 wks, 3, 6 mo, 2, 5, 10 years ]
- Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10 [ Time Frame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years ]
- Percentage of patients with acceptable symptom state (PASS) [ Time Frame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Over 18 years old patient who agrees to the consent to participation in this study
- Unilateral dislocated humeral shaft fracture (dislocation over thickness of the bone cortex, fracture below the level of insertion of pectoralis major muscle and 5 cm above the olecranon fossa)
- Randomization can be done within 10 days and operation within 14 days after the initial trauma
- Patient is willing to participate all follow-up visits
Exclusion Criteria:
- Bilateral humeral shaft fracture
- A significant concomitant trauma of the same upper extremity that warrants operative treatment (fracture, tendon injury, soft tissue trauma)
- Other fracture or abdominal/thoracal trauma that warrants operative treatment
- Open fracture
- Pathological fracture
- Multi-trauma patient
- Vascular injury
- Plexus injury
- Previous trauma in the same upper extremity that causes functional deficit
- Trauma or condition that warrants use of walking aid (crutches, wheelchair etc)
- Disease that affects significantly general condition of the patient
- Significantly impaired ability to co-operate for any reason (substance abuse, mental disorder, dementia)
- Unwilling to accept both treatment methods

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719887
Finland | |
Töölö Hospital, Helsinki University Central Hospital | |
Helsinki, Finland | |
Tampere University Hospital | |
Tampere, Finland |
Study Director: | Mika Paavola, MD, PhD | Töölö Hospital |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lasse Ramo, MD, Töölö Hospital |
ClinicalTrials.gov Identifier: | NCT01719887 |
Other Study ID Numbers: |
HUS-118/13/03/02/2012 |
First Posted: | November 1, 2012 Key Record Dates |
Last Update Posted: | August 21, 2020 |
Last Verified: | August 2020 |
humerus humeral shaft |
diaphysis fracture RCT |
Fractures, Bone Wounds and Injuries |