Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

NCT03172715 | Recruiting DMC

• 1 other identifier: Dnro 6U/2017
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 8

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.

Conditions

Tibial Fractures

Keywords

Open reduction internal fixation; Arthroplasty; Surgery; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Knee function

  Oxford knee score 12 months after randomisation

  12 months

Secondary Outcomes (6)

• Change in knee function

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

• Change in pain

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

• Change in physical performance

  6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

• Change in quality of life

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

• Reoperations

  Up to 10 years following randomisation

Other Outcomes (4)

• Pain medication

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

• Complications

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

• Medical and social services (quantity)

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

Study Arms (2)

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.

Procedure: Locking plate

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.

Procedure: TKR

Interventions

Locking plate PROCEDURE

Osteosynthesis

ORIF (open reduction-internal fixation)

TKR PROCEDURE

Total knee arthroplasty

TKR (total knee replacement)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Finland Hospital District: lead
• Tampere University Hospital: collaborator
• Coxa, Hospital for Joint Replacement: collaborator
• Oulu University Hospital: collaborator
• Turku University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Seinajoki Central Hospital: collaborator
• Paijat-Hame Hospital District: collaborator

Study Sites (8)

Central Finland Hospital

Jyväskylä, 40620, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

NOT YET RECRUITING

Päijät-Häme Central Hospital

Lahti, Finland

NOT YET RECRUITING

Oulu University Hospital

Oulu, Finland

NOT YET RECRUITING

Seinäjoki Central Hospital

Seinäjoki, Finland

NOT YET RECRUITING

Coxa Joint Replacement Hospital

Tampere, Finland

NOT YET RECRUITING

Tampere University Hospital

Tampere, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, Finland

NOT YET RECRUITING

Related Publications (7)

• 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.

  PMID: 26264176 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.

  PMID: 24430414 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.

  PMID: 24694275 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.

  PMID: 21763651 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.

  PMID: 23771128 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.

  PMID: 26671570 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.

  PMID: 26885510 BACKGROUND

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Juha Paloneva, MD, PhD

  Central Finland Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juha Paloneva, MD, PhD

CONTACT

+358 14 2693119; juha.paloneva@ksshp.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department head, adjunct professor

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: June 1, 2017
• Study Start: January 9, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (8)