Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regionshospitalet Horsens | OTHER |
| Aarhus University Hospital | OTHER |
| Regionshospitalet Viborg, Skive | OTHER |
| Kolding Sygehus |
Not provided
Not provided
Not provided
Not provided
Simple displaced olecranon fractures are most often treated with tension band wiring. This is an effective treatment, but the risk of subsequent re-operation is high. The investigators propose open reduction and internal fixation with a strong suture, thus reducing the risk of re-operation significantly.
Background Olecranon fractures are frequent with an incidence of 11.5 per 100.000 people per year. Olecranon fractures are classified according to the Mayo classification in three groups. Type 1A and B are treated conservatively, while comminute fractures of type Mayo 2B and 3B are treated with plate osteosynthesis.
The most common type is a simple two part fracture, Mayo type 2A, which represents 74% of all olecranon fractures. The typical treatment of Mayo type 2A fractures is osteosynthesis using k-wires and tension band wiring. This provides adequate fracture healing and good functional results. The use of plate osteosynthesis for Mayo type 2A fractures does not provide functional or health economic benefits compared with operation with tension band wiring.
Common for both techniques is a high risk of re-operation due to delayed healing of the surgical wound, and complications arising from the implanted material.
Recently, new techniques for Mayo type 2A fractures have been described, in which no metal is implanted. Osteosynthesis is achieved with strong sutures. These techniques have been shown to reduce the high risk of complications leading to re-operation without effecting the functional outcome or fracture healing rate.
Hypothesis The investigators hypothesize that suture fixation of Mayo type 2A fractures will decrease the risk of re-operation and provide equal functional outcome compared with tension band wiring.
Design Prospective, randomized multicenter study
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-wire tension band wiring | Active Comparator | The patient is treated with 1.6 mm k-wires and 1 mm cerclage |
|
| Suture fixation | Active Comparator | The fracture is reduced and fixed with 2.0 Orthocord suture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture fixation | Procedure | The fracture is reduced. A 2.5 mm hole is drilled in the dorsal olecranon 15mm from the fracture. A suture is passed through the hole and is fixed to the triceps muscle. A second suture is fixed to the triceps muscle in a figure 8 configuration. |
| Measure | Description | Time Frame |
|---|---|---|
| Re-operation | The rate of re-operation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score | Patient reported outcome measure. Range from 0 (No disability) to 100 (most severe disability). | 1 year |
| European Quality of life - 5 Dimensions (EQ-5D) questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Qvist, MD | Contact | +45 9764 3000 | andreas.christensen@rn.dk | |
| Bjørn Christensen, MD, PhD | Contact | +4522449180 | bjornbc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Qvist, MD | Aalborg University Hostipital | Principal Investigator |
| Andreas Haubjerg Qvist, MD | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Sygehus - Farsø | Recruiting | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22077988 | Background | Duckworth AD, Clement ND, Aitken SA, Court-Brown CM, McQueen MM. The epidemiology of fractures of the proximal ulna. Injury. 2012 Mar;43(3):343-6. doi: 10.1016/j.injury.2011.10.017. Epub 2011 Nov 9. | |
| 8666617 | Background | Ates Y, Atlihan D, Yildirim H. Current concepts in the treatment of fractures of the radial head, the olecranon and the coronoid. J Bone Joint Surg Am. 1996 Jun;78(6):969. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000092470 | Olecranon Fracture |
| ID | Term |
|---|---|
| D000092482 | Elbow Fractures |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| OTHER |
| Randers Regional Hospital | OTHER |
Two study arms. One arm is treated with k-wire tension band wiring and one leg is treated with suture fixation
Not provided
Not provided
An envelope deciding the treatment modality is drawn while the patient is anesthetized. Post operative follow-up is performed by blinded assessors. The treatment will be revealed after one year, or if the patient is excluded from the study.
Patient reported outcome measure. Score from 1 (best) to 3 (worst) in 5 different categories.
| 1 year |
| Range of motion | Range of motion in elbow | 1 year |
| Sick days | Number of sick days/Return to work | 1 year |
| Non-union | Rate of non-union | 6 months |
| Rate of complications | Rate of complications to the treatment: Infection, nerve damage, delayed wound healing. | 1 year |
| 25426876 | Background | Matar HE, Ali AA, Buckley S, Garlick NI, Atkinson HD. Surgical interventions for treating fractures of the olecranon in adults. Cochrane Database Syst Rev. 2014 Nov 26;2014(11):CD010144. doi: 10.1002/14651858.CD010144.pub2. |
| 28763412 | Background | Duckworth AD, Clement ND, White TO, Court-Brown CM, McQueen MM. Plate Versus Tension-Band Wire Fixation for Olecranon Fractures: A Prospective Randomized Trial. J Bone Joint Surg Am. 2017 Aug 2;99(15):1261-1273. doi: 10.2106/JBJS.16.00773. |
| 3440616 | Background | Helm RH, Hornby R, Miller SW. The complications of surgical treatment of displaced fractures of the olecranon. Injury. 1987 Jan;18(1):48-50. doi: 10.1016/0020-1383(87)90386-x. |
| 10982677 | Background | Romero JM, Miran A, Jensen CH. Complications and re-operation rate after tension-band wiring of olecranon fractures. J Orthop Sci. 2000;5(4):318-20. doi: 10.1007/s007760070036. |
| 24893946 | Background | Snoddy MC, Lang MF, An TJ, Mitchell PM, Grantham WJ, Hooe BS, Kay HF, Bhatia R, Thakore RV, Evans JM, Obremskey WT, Sethi MK. Olecranon fractures: factors influencing re-operation. Int Orthop. 2014 Aug;38(8):1711-6. doi: 10.1007/s00264-014-2378-y. Epub 2014 Jun 4. |
| 3908460 | Background | Macko D, Szabo RM. Complications of tension-band wiring of olecranon fractures. J Bone Joint Surg Am. 1985 Dec;67(9):1396-401. |
| 28932288 | Background | Phadnis J, Watts AC. Tension band suture fixation for olecranon fractures. Shoulder Elbow. 2017 Oct;9(4):299-303. doi: 10.1177/1758573216687305. Epub 2017 Jan 18. |
| 26630656 | Background | Das AK, Jariwala A, Watts AC. Suture Repair of Simple Transverse Olecranon Fractures and Chevron Olecranon Osteotomy. Tech Hand Up Extrem Surg. 2016 Mar;20(1):1-5. doi: 10.1097/BTH.0000000000000106. |
| 20937160 | Background | Nimura A, Nakagawa T, Wakabayashi Y, Sekiya I, Okawa A, Muneta T. Repair of olecranon fractures using fiberWire without metallic implants: report of two cases. J Orthop Surg Res. 2010 Oct 12;5:73. doi: 10.1186/1749-799X-5-73. |
| 8773720 | Background | Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L. |
| 10109801 | Background | EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. |
| 12809562 | Background | Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16. |
| 11861726 | Background | Hunsaker FG, Cioffi DA, Amadio PC, Wright JG, Caughlin B. The American academy of orthopaedic surgeons outcomes instruments: normative values from the general population. J Bone Joint Surg Am. 2002 Feb;84(2):208-15. doi: 10.2106/00004623-200202000-00007. |
| 39575943 | Derived | Qvist AH, Christensen BB. Suture fixation versus tension band wiring in simple displaced olecranon fractures - a study protocol. Dan Med J. 2024 Oct 18;71(11):A01240038. doi: 10.61409/A01240038. |
| D014458 |
| Ulna Fractures |
| D005543 | Forearm Injuries |
| D050723 | Fractures, Bone |