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Operative treatment, with tension band wiring or plate fixation, will be compared with non-operative treatment of displaced olecranon fractures (Mayo classification 2A and 2B) in patients 75 years or older.
Displaced olecranon fractures disrupt the extensor mechanism of the elbow and operative treatment is therefore usually recommended. Tension band wiring (TBW) and plate fixation (PF) are the most common surgical treatment options. Both methods are associated with high complication and reoperation rates, especially in elderly patients. Only one randomized controlled trial has compared operative and non-operative treatment of olecranon fractures in the elderly, but the study was stopped prematurely due to high complication rates in the group treated operatively and remained underpowered for important outcome measures.A few small patient series with non-operatively treated fractures also exist and suggest that it may be a valid alternative to operative treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative | Active Comparator | Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate. |
|
| Non-operative | Experimental | Patients will be offered a plaster cast for 1-2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tension band wiring or plate fixation | Procedure | Choice of operative treatment is TBW or PF with a precontoured anatomical plate. The treating surgeon decides if TBW or PF is chosen as operative treatment method. The surgeries are performed according to OTA principles by an experienced surgeon, a trauma fellow or a consultant as approved by the participating hospitals. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Elbow Score | Patient reported 12 item form, 0 (worst) to 100 (best possible score) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Range of motion | Extension, flexion, rotation | 6 weeks |
| Range of motion | Extension, flexion, rotation | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frede Frihagen, PhD | Contact | +4791332738 | ffrihagen@gmail.com | |
| Kaare S Midtgaard, MD | Contact | +4793412696 | Kaare.midtgaard@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Frede Frihagen, PhD | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baerum Hospital | Recruiting | Sandvika | Gjettum | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32818066 | Background | Savvidou OD, Koutsouradis P, Kaspiris A, Naar L, Chloros GD, Papagelopoulos PJ. Displaced olecranon fractures in the elderly: outcomes after non-operative treatment - a narrative review. EFORT Open Rev. 2020 Aug 1;5(7):391-397. doi: 10.1302/2058-5241.5.190041. eCollection 2020 Jul. |
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Publish protocol
Within 12 months
Open access
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| ID | Term |
|---|---|
| D000092470 | Olecranon Fracture |
| ID | Term |
|---|---|
| D000092482 | Elbow Fractures |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
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Randomized non-inferiority multicenter
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Patient instructed not to reveal treatment and to wear long sleeves.
|
| Active non-operative treatment with optional plaster cast | Procedure | Patients allocated to non-operative treatment are offered a back-slab in 60 degrees of flexion for pain-relief. The back-slab is removed 7-14 days following injury. |
|
| Range of motion | Extension, flexion, rotation measured in degrees total movement for each direction. | 52 weeks |
| Elbow extension strength | Strength measured isometrically on a scale (grams) with elbow in 30 degrees flexion. Both arms measured for comparison. | 6 weeks |
| Elbow extension strength | Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. | 12 weeks |
| Elbow extension strength | Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. arms measured for comparison. | 52 weeks |
| Elbow satisfaction | Single question: Are you satisfied with your elbow? Yes/Somewhat/No | 6 weeks |
| Elbow satisfaction | Single question: Are you satisfied with your elbow? Yes/Somewhat/No | 12 weeks |
| Elbow satisfaction | Single question: Are you satisfied with your elbow? Yes/Somewhat/No | 52 weeks |
| Complications | Serious local complications not reoperated. | Through study period up to 52 weeks. |
| Number of Reoperations | Any reoperation | Through study period up to 52 weeks. |
| Oxford Elbow Score | Patient reported 12 item form, 0 (worst) to 100 (best possible score) | 6 weeks |
| Oxford Elbow Score | Patient reported 12 item form, 0 (worst) to 100 (best possible score) | 12 weeks |
| Vestre Viken Hospital Trust | Recruiting | Hønefoss | Norway | 3511 | Norway |
|
| St. Olavs Hospital | Recruiting | Trondheim | Trønderlag | Norway |
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| Arendal Hospital | Recruiting | Arendal | Norway |
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| Haukeland University Hospital | Recruiting | Bergen | Norway |
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| Østfold Hospital Trust | Recruiting | Grålum | Norway |
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| Orthopedic Center, Ulleval University Hospital | Recruiting | Oslo | 0408 | Norway |
| Diakonhjemmet Hospital | Not yet recruiting | Oslo | Norway |
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| Telemark Hospital | Recruiting | Skien | Norway |
|
| Stavanger University Hospital | Recruiting | Stavanger | Norway |
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| Tønsberg Hospital | Recruiting | Tønsberg | Norway |
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| Akademiska Hospital | Not yet recruiting | Uppsala | Sweden |
|
| D014458 |
| Ulna Fractures |
| D005543 | Forearm Injuries |
| D050723 | Fractures, Bone |