Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

Tibial Fractures Clinical Trial

— POSITIF  

Official title:

Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03172715
• Other study ID #: Dnro 6U/2017
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: June 2029

Study information

• Verified date: February 2024
• Source: Central Finland Hospital District
• Contact: Juha Paloneva, MD, PhD
• Phone: +358 14 2693119
• Email: juha.paloneva[@]ksshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: June 2029
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Acute intra-articular proximal tibia fracture with impression of the joint cartilage (Schatzker grades II to VI)
• Impression of tibial plateau min 2 mm
• Intact patellar tendon
• The patient accepts both treatment options (osteosynthesis and arthroplasty)

Exclusion Criteria:

• Not voluntary
• Previous arthroplasty of the knee
• Previous fracture affecting the knee joint
• Inability to co-operate
• Not independent (institutionalized living before fracture)
• Severe osteoarthritis (Kellgren-Lawrence grade 4)
• Open fracture (Gustilo grade 2 or over)
• Progressive metastatic malign disease
• Multiple fractures requiring operative treatment
• Severe soft tissue injury around the knee (Tscherne classification grade 3)
• Avulsion fracture of the patellar tendon or concomitant patellar tendon tear
• Inability to walk before fracture
• Severe medical comorbidities
• Body Mass Index over 40
• Unacceptably high risk of surgery due to severe medical comorbidities
• Significant arterial or nerve trauma
• Severe substance abuse

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

Procedure:
• Locking plate
Osteosynthesis
• TKR
Total knee arthroplasty

Locations

Country	Name	City	State
Finland	Central Finland Hospital	Jyväskylä
Finland	Kuopio University Hospital	Kuopio
Finland	Päijät-Häme Central Hospital	Lahti
Finland	Oulu University Hospital	Oulu
Finland	Seinäjoki Central Hospital	Seinäjoki
Finland	Coxa Joint Replacement Hospital	Tampere
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (8)

Lead Sponsor	Collaborator
Central Finland Hospital District	Coxa, Hospital for Joint Replacement, Kuopio University Hospital, Oulu University Hospital, Paijat-Hame Hospital District, Seinajoki Central Hospital, Tampere University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain medication	Pain medication used (pills per day)	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Other	Complications	Any complication following injury or treatment	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Other	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
Other	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
Primary	Knee function	Oxford knee score 12 months after randomisation	12 months
Secondary	Change in knee function	Change in Oxford knee score	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Secondary	Change in pain	Numeric rating scale (rest, night, exercise)	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Secondary	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
Secondary	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
Secondary	Reoperations	Need for revision surgery	Up to 10 years following randomisation
Secondary	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