Tibial FracturesPOSITIFNCT03172715
Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures
A study testing Locking plate and TKR in people with Tibial Fractures, run by Central Finland Hospital District at 8 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- Locking plate and TKR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 8 sitesFinland
- Study dates
- 9 Jan 2018to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Finland8 sites, 8 recruiting
- Recruiting
Central Finland Hospital
Jyväskylä, 40620
Juha Paloneva, MD, PhD, +358 14 2693119
Valtteri Tapper, MD
- Not yet recruiting
Kuopio University Hospital
Kuopio
Jussi Jalkanen, MD
Jussi Jalkanen, MD, PhD
- Not yet recruiting
Päijät-Häme Central Hospital
Lahti
Jussi Haapala, MD, PhD
Jussi Haapala, MD, PhD
- Not yet recruiting
Oulu University Hospital
Oulu
Tuukka Niinimäki, MD, PhD
Tuukka Niinimäki, MD, PhD
- Not yet recruiting
Seinäjoki Central Hospital
Seinäjoki
Janne Jousmäki, MD, PhD
Janne Jousmäki, MD, PhD
- Not yet recruiting
Coxa Joint Replacement Hospital
Tampere
Jyrki Nieminen, MD
Jyrki Nieminen, MD, PhD
- Not yet recruiting
Tampere University Hospital
Tampere
Minna Laitinen, MD, PhD
Ilari Pajamäki, MD
- Not yet recruiting
Turku University Hospital
Turku
Niko Strandberg, MD, PhD
Niko Strandberg, MD, PhD
About this study
Official title: Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial
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.
Read the 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.
- Conditions
- Tibial Fractures
- Being tested
- Locking plate, TKR
- Keywords
- Open reduction internal fixation, Arthroplasty, Surgery, Randomized controlled trial
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locking plateProcedure or surgery
Osteosynthesis
TKRProcedure or surgery
Total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: TKR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee function
Oxford knee score 12 months after randomisation
Measured: 12 months
Secondary outcomes (6)
Change in knee function
Change in Oxford knee score
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Change in pain
Numeric rating scale (rest, night, exercise)
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Change in physical performance
Short Physical Performance Battery (SPPB)
Measured: 6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Change in quality of life
Short form-36 (SF-36)
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Reoperations
Need for revision surgery
Measured: Up to 10 years following randomisation
Satisfaction
Satisfaction with knee (Numeric rating scale, range 0 to 10)
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start9 Jan 2018
- Primary completionJun 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Coxa, Hospital for Joint Replacement, Oulu University Hospital, Turku University Hospital, Kuopio University Hospital, Seinajoki Central Hospital, Paijat-Hame Hospital District
- Responsible party
- Principal investigator, Juha Paloneva, Central Finland Hospital District
- Investigators
- Juha Paloneva, MD, PhD, Principal investigator, Central Finland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172715
- Sponsor's protocol ID
- Dnro 6U/2017
- Acronym
- POSITIF
- Status last verified
- Aug 2024
- First submitted
- 22 May 2017
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26264176Wasserstein 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.
PubMed 24430414Somersalo 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.
PubMed 24694275Malviya 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.
PubMed 21763651Kini 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.
PubMed 23771128Shimizu 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.
PubMed 26671570Haufe 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.
PubMed 26885510
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial
- ClinicalTrials.gov ID
- NCT03172715
- Acronym / sponsor ID
- POSITIF / Dnro 6U/2017
- Conditions
- Tibial Fractures
- Keywords
- Open reduction internal fixation, Arthroplasty, Surgery, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Coxa, Hospital for Joint Replacement, Oulu University Hospital, Turku University Hospital, Kuopio University Hospital, Seinajoki Central Hospital, Paijat-Hame Hospital District
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORIF (open reduction-internal fixation) | Active comparator | Procedure: Locking plateOsteosynthesis 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. |
| TKR (total knee replacement) | Experimental | Procedure: TKRArthroplasty 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (17 listed)
- Not voluntary
- Previous arthroplasty of the knee
- Previous fracture affecting the knee joint
- Inability to co-operate
- Not independent (institutionalized living before fracture)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locking plateOsteosynthesis | Procedure or surgery | ORIF (open reduction-internal fixation) |
| TKRTotal knee arthroplasty | Procedure or surgery | TKR (total knee replacement) |
Primary outcome
Knee function
Time frame: 12 months
Oxford knee score 12 months after randomisation
6 secondary outcomes
Change in knee function
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Change in pain
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Change in physical performance
Time frame: 6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Change in quality of life
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Reoperations
Time frame: Up to 10 years following randomisation
Satisfaction
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 26264176Houdek 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.
- Background: PubMed 24430414Wasserstein 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.
- Background: PubMed 24694275Somersalo 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.
- Background: PubMed 21763651Malviya 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.
- Background: PubMed 23771128Kini 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.
- Background: PubMed 26671570Shimizu 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.
- Background: PubMed 26885510Haufe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juha Paloneva, MD, PhD principal investigator
Central Finland Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locking plate and TKR in people with Tibial Fractures, run by Central Finland Hospital District at 8 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juha Paloneva, MD, PhD (+358 14 2693119, juha.paloneva@ksshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03172715, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.