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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Tampere University Hospital | OTHER |
| Finnish Institute for Health and Welfare | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative treatment | Active Comparator | Conservative treatment with functional brace and physiotherapy. |
|
| Operative treatment | Experimental | Operative treatment with open reduction and internal fixation with 4,5mm locking compression plate. Physiotherapy at 3 and 9 wks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative treatment | Device | Conservative treatment with functional brace. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Disabilities of the Arm, Shoulder and Hand Score (DASH) | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective assessment of the function of the upper extremity | Numerical Rating Scale (NRS) 0-10 | 6 wks, 3, 6, 12 mo, 2, 5, 10 years |
| Constant Score | 6 wks, 3, 6, 12 mo, 2, 5, 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mika Paavola, MD, PhD | Töölö Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Töölö Hospital, Helsinki University Central Hospital | Helsinki | Finland | ||||
| Tampere University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28694341 | Background | Ramo L, Taimela S, Lepola V, Malmivaara A, Lahdeoja T, Paavola M. Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort. BMJ Open. 2017 Jul 9;7(7):e014076. doi: 10.1136/bmjopen-2016-014076. | |
| 32396179 |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Operative treatment |
| Procedure |
Operative treatment with open reduction and internal fixation using 4,5mm locking compression plate. |
|
| Physiotherapy | Other | Physiotherapy is arranged to both groups at 3 and 9 wks. |
|
| Elbow ROM | 6 wks, 3, 6, 12 mo, 2, 5, 10 years |
| Health-related quality of life (15D) | 6 wks, 3, 6, 12 mo, 2, 5, 10 years |
| Complications | Incidence of complications (i.e. non-union, malunion, re-fracture, reoperation, infection and iatrogenic radial palsy) is recorded and compared between study groups. | 6 wks, 3, 6, 12 mo, 2, 5, 10 years |
| Cost-effectiveness | Quality-adjusted life years/months measured as a change in 15D tool, pain-NRS and other outcome measures. | 6 wks, 3, 6, 12 mo, 2, 5, 10 years |
| Subjective assessment of the function of the upper extremity | Likert Scale 1-7 | 6 wks, 3, 6, 12 mo, 2, 5, 10 years |
| Subjective assessment of the function of the elbow | Numerical Rating Scale (NRS) 0-10 | 6 wks, 3, 6, 12 mo, 2, 5, 10 years |
| The Disabilities of the Arm, Shoulder and Hand Score (DASH) | at 6 wks, 3, 6 mo, 2, 5, 10 years |
| Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10 | at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years |
| Percentage of patients with acceptable symptom state (PASS) | at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years |
| Tampere |
| Finland |
| Ramo L, Sumrein BO, Lepola V, Lahdeoja T, Ranstam J, Paavola M, Jarvinen T, Taimela S; FISH Investigators. Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial. JAMA. 2020 May 12;323(18):1792-1801. doi: 10.1001/jama.2020.3182. |
| 33851991 | Result | Ramo L, Paavola M, Sumrein BO, Lepola V, Lahdeoja T, Ranstam J, Jarvinen TLN, Taimela S; FISH Investigators. Outcomes With Surgery vs Functional Bracing for Patients With Closed, Displaced Humeral Shaft Fractures and the Need for Secondary Surgery: A Prespecified Secondary Analysis of the FISH Randomized Clinical Trial. JAMA Surg. 2021 Apr 14;156(6):1-9. doi: 10.1001/jamasurg.2021.0906. Online ahead of print. |
| 38436996 | Result | Ramo L, Ibounig T, Sumrein BO, Lepola V, Paavola M, Taimela S, Jarvinen TLN; FISH Investigators. Five-Year Follow-Up of Surgery vs Functional Bracing for Closed Displaced Humeral Shaft Fractures. JAMA. 2024 Apr 2;331(13):1149-1151. doi: 10.1001/jama.2024.2671. |
| 36357855 | Derived | Ibounig T, Juurakko J, Lahdeoja T, Sumrein BO, Jarvinen TLN, Paavola M, Ardern CL, Karjalainen T, Taimela S, Ramo L. Minimal important difference and patient acceptable symptom state for common outcome instruments in patients with a closed humeral shaft fracture - analysis of the FISH randomised clinical trial data. BMC Med Res Methodol. 2022 Nov 10;22(1):291. doi: 10.1186/s12874-022-01776-6. |