Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2029-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tibial Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ORIF (open reduction-internal fixation)

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.

Group Type ACTIVE_COMPARATOR

Locking plate

Intervention Type PROCEDURE

Osteosynthesis

TKR (total knee replacement)

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.

Group Type EXPERIMENTAL

TKR

Intervention Type PROCEDURE

Total knee arthroplasty

Interventions

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Locking plate

Osteosynthesis

Intervention Type PROCEDURE

TKR

Total knee arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Juha Paloneva

Department head, adjunct professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juha Paloneva, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Finland Hospital

Locations

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Central Finland Hospital

Jyväskylä, , Finland

Site Status RECRUITING