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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
| Coxa, Hospital for Joint Replacement | OTHER |
| Oulu University Hospital | OTHER |
| Turku University Hospital |
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The aim of this study is to compare knee function and pain one year after treatment of intra-articular proximal tibia fracture using either osteosynthesis with a locking plate (ORIF) or primary total knee replacement (TKR) in patients over 65 years of age.
Intra-articular proximal tibial fractures are relatively common in the elderly. They constitute 8% of all fractures in patients over 65 years. Open reduction and internal fixation (ORIF) is the golden standard treatment for these fractures.
The treatment with ORIF is associated with significant co-morbidity due to complicating concomitant factors, such as osteoporosis, poor co-operation, infection and inadequate stability of osteosynthesis. A high failure rate (30-79 %) of fixation of tibia plateau fractures in elderly people has been reported. Most of these fractures occur in elderly persons who are at risk to lose their ability to walk independently, because of partial immobilization is required initially and full weight bearing is not allowed during 6 to 8 weeks after the operation. The risk of post-traumatic osteoarthritis has been reported to be 5.3-times higher than in the normal population even if adequate stability is achieved and other conditions normalized for fracture healing. It has also been reported that total knee replacement (TKR) performed for post-traumatic arthritis after tibial plateau fracture lead to worse outcome compared with TKR due to primary osteoarthritis. In addition, previous operations increase the risk of complications after TKR. The complication rate in secondary TKR has been reported to be over 18 %.
The available data regarding TKR as a primary treatment option for proximal tibial plateau fracture suggest that fast mobilization and return to normal daily activities may be achieved. These data also suggest a low rate of complications. There are no randomized controlled trials comparing the outcomes of the traditional treatment option (open reduction- internal fixation, ORIF) and TKR as primary treatment of these fractures. In this study investigators compare the outcomes of locking plate osteosynthesis and total knee arthroplasty according to Oxford knee score, pain, ability to walk, or quality of life one year after randomization in 98 patients aged over 65 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORIF (open reduction-internal fixation) | Active Comparator | Osteosynthesis with locking plate(s) will be performed using medial and/or lateral incision, according to morphology of the fracture. Additional osteosynthesis material will be used when necessary. The articular surface will be reduced and bone transplantation or bone substitute used if required. Postoperatively, touch-down weight bearing will be allowed for 6 weeks, followed by 2 weeks of half-weight-bearing period. A walker or wheelchair will be used when necessary. |
|
| TKR (total knee replacement) | Experimental | Arthroplasty of the knee will be performed within two weeks after the fracture. Medial parapatellar approach will be used. The minimal possible constraint of the prosthesis (cruciate retaining, posterior cruciate sacrificing or semi-constrained) will be used. A possible insufficient bone stock may be rebuilt with augments. Hinged prosthesis will be used only if stability of the medial collateral ligament is insufficient. A cemented or uncemented tibial stem extender (minimum length 50mm) will be used in all cases. Additional osteosynthesis will be used when necessary. Postoperatively, the patients will be allowed full weight bearing as tolerated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Locking plate | Procedure | Osteosynthesis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Knee function | Oxford knee score 12 months after randomisation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in knee function | Change in Oxford knee score | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years |
| Change in pain | Numeric rating scale (rest, night, exercise) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain medication | Pain medication used (pills per day) | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years |
| Complications | Any complication following injury or treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juha Paloneva, MD, PhD | Contact | +358 14 2693119 | juha.paloneva@ksshp.fi |
| Name | Affiliation | Role |
|---|---|---|
| Juha Paloneva, MD, PhD | Central Finland Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Finland Hospital | Recruiting | Jyväskylä | 40620 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26264176 | Background | Houdek MT, Watts CD, Shannon SF, Wagner ER, Sems SA, Sierra RJ. Posttraumatic Total Knee Arthroplasty Continues to Have Worse Outcome Than Total Knee Arthroplasty for Osteoarthritis. J Arthroplasty. 2016 Jan;31(1):118-23. doi: 10.1016/j.arth.2015.07.022. Epub 2015 Jul 17. | |
| 24430414 | Background | Wasserstein D, Henry P, Paterson JM, Kreder HJ, Jenkinson R. Risk of total knee arthroplasty after operatively treated tibial plateau fracture: a matched-population-based cohort study. J Bone Joint Surg Am. 2014 Jan 15;96(2):144-50. doi: 10.2106/JBJS.L.01691. |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| OTHER_GOV |
| Kuopio University Hospital | OTHER |
| Seinajoki Central Hospital | OTHER |
| Paijat-Hame Hospital District | OTHER |
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| TKR |
| Procedure |
Total knee arthroplasty |
|
| Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years |
| Change in physical performance | Short Physical Performance Battery (SPPB) | 6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years |
| Change in quality of life | Short form-36 (SF-36) | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years |
| Reoperations | Need for revision surgery | Up to 10 years following randomisation |
| Satisfaction | Satisfaction with knee (Numeric rating scale, range 0 to 10) | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years |
| Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years |
| Medical and social services (quantity) | Use of medical and social services (quantity) | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years |
| Medical and social services (costs) | Costs of medical and social services used | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years |
| Kuopio University Hospital | Not yet recruiting | Kuopio | Finland |
|
| Päijät-Häme Central Hospital | Not yet recruiting | Lahti | Finland |
|
| Oulu University Hospital | Not yet recruiting | Oulu | Finland |
|
| Seinäjoki Central Hospital | Not yet recruiting | Seinäjoki | Finland |
|
| Coxa Joint Replacement Hospital | Not yet recruiting | Tampere | Finland |
|
| Tampere University Hospital | Not yet recruiting | Tampere | Finland |
|
| Turku University Hospital | Not yet recruiting | Turku | Finland |
|
| 24694275 | Background | Somersalo A, Paloneva J, Kautiainen H, Lonnroos E, Heinanen M, Kiviranta I. Incidence of fractures requiring inpatient care. Acta Orthop. 2014 Sep;85(5):525-30. doi: 10.3109/17453674.2014.908340. Epub 2014 Apr 3. |
| 21763651 | Background | Malviya A, Reed MR, Partington PF. Acute primary total knee arthroplasty for peri-articular knee fractures in patients over 65 years of age. Injury. 2011 Nov;42(11):1368-71. doi: 10.1016/j.injury.2011.06.198. Epub 2011 Jul 18. |
| 23771128 | Background | Kini SG, Sathappan SS. Role of navigated total knee arthroplasty for acute tibial fractures in the elderly. Arch Orthop Trauma Surg. 2013 Aug;133(8):1149-54. doi: 10.1007/s00402-013-1792-8. Epub 2013 Jun 16. |
| 26671570 | Background | Shimizu T, Sawaguchi T, Sakagoshi D, Goshima K, Shigemoto K, Hatsuchi Y. Geriatric tibial plateau fractures: Clinical features and surgical outcomes. J Orthop Sci. 2016 Jan;21(1):68-73. doi: 10.1016/j.jos.2015.09.008. Epub 2015 Dec 6. |
| 26885510 | Background | Haufe T, Forch S, Muller P, Plath J, Mayr E. The Role of a Primary Arthroplasty in the Treatment of Proximal Tibia Fractures in Orthogeriatric Patients. Biomed Res Int. 2016;2016:6047876. doi: 10.1155/2016/6047876. Epub 2016 Jan 18. |