Locking plate
ProcedureOsteosynthesis
NCT Number: NCT03172715
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Central Finland Hospital, Jyväskylä, Finland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Osteosynthesis
Total knee arthroplasty
Time frame: 12 months
Oxford knee score 12 months after randomisation
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Change in Oxford knee score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Numeric rating scale (rest, night, exercise)
Time frame: 6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Short Physical Performance Battery (SPPB)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Short form-36 (SF-36)
Time frame: Up to 10 years following randomisation
Need for revision surgery
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Satisfaction with knee (Numeric rating scale, range 0 to 10)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Pain medication used (pills per day)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Any complication following injury or treatment
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Use of medical and social services (quantity)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Costs of medical and social services used
Contact information is provided by the study sponsor or research team.
Central Finland Hospital District
Other
Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial
Acronym: POSITIF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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