Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

Not Applicable

Recruiting

• Conditions: Tibial Fractures

• Registration Number: NCT03172715
• Lead Sponsor: Central Finland Hospital District

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-01
• Study Start: 2018-01-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2026-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knee function	12 months	Oxford knee score 12 months after randomisation

Secondary Outcome Measures

Name	Time	Method
Reoperations	Up to 10 years following randomisation	Need for revision surgery
Change in quality of life	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years	Short form-36 (SF-36)
Change in knee function	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years	Change in Oxford knee score
Satisfaction	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)
Change in physical performance	6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years	Short Physical Performance Battery (SPPB)
Change in pain	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years	Numeric rating scale (rest, night, exercise)

Trial Locations

Locations (8)

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, Finland