OsteoarthritisTi-TanNCT00138853
A Roentgen Stereophotogrammetric Analysis on Migration of Knee Prostheses.
A study testing Tibial component in people with Osteoarthritis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to compare the early migration of two uncemented total knee arthroplasties with different metal coating. Only the tibial prosthesis plateau varies. One is made out of tantalum and has two short pegs for fixation into the tibia while the other is covered by titanium fiber-mesh on the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Tibial component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2003to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with one- or double-sided primary knee arthrosis.
- Patients with a sufficient bone quality for implantation of an uncemented prosthesis.
- Informed and written patient consent.
Who cannot join
- Patients with neuromuscular or vascular diseases in the affected leg.
- Patients who peroperatively are estimated unsuitable for an uncemented knee arthroplasty e.g. due to bone cysts or dilution of the bone mass.
- Patients who use non-steroid anti-inflammatory drugs (NSAID) and cannot refrain from taking them postoperatively (this includes COX-2-inhibitors).
- Patients with osteoporosis estimated from the preoperative x-ray or former diagnosis of osteoporosis.
- Patients with fracture sequelae.
- Women, who are pregnant or are at risk of getting pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Roentgen Stereophotogrammetric Analysis on Migration of Knee Prostheses. A Randomised Prospective Study of Tantalum Versus Titanium Implants.
The purpose of this study is to compare the early migration of two uncemented total knee arthroplasties with different metal coating. Only the tibial prosthesis plateau varies. One is made out of tantalum and has two short pegs for fixation into the tibia while the other is covered by titanium fiber-mesh on the bone-near site and has 4 short pegs for screw fixation into the tibia.
Read the detailed description
Around 4% of total knee arthroplasties (TKA) are revised 15 years after the primary operation, most due to loosening of the implant. The use of uncemented prostheses are expected to extend the fixation time and thereby the years of TKA survival. When a cementless implant is inserted, direct bone ingrowth to the implant depends on a complete primary stabilisation. Movement between the bone and implant will cause a fibrous membrane leading to micromotions. Micromotions can be evaluated by radiophotogrammetric analysis (RSA) in early follow-up and they have been shown to be a prognostic marker for painful loosening of the implant.
Tantalum is a fairly new biomaterial designed with a high and bone-binding porosity. Tantalum has already proven to be a good prosthesis material facilitating fast bone-ingrowth and supplying mechanical qualities in the bone-prosthesis interface that surpasses the qualities of regular prosthesis materials by uncemented method. Titanium on the other hand has been used as a prosthesis coating for years and also promote prosthesis fixation by osteointegration.
The purpose of this study is to compare the early migration of two uncemented total knee implants with different metal coating and fixation method. Only the tibial prosthesis plateau varies in design. One plateau is a 2 pegged tantalum monobloc and the other plateau is a modular titanium fiber-mesh coating with 4 short pegs for screw fixation into the tibia.
Furthermore the extend of the expected micromovements between the polyethylene liner and the metal backing of the titanium plateau will be compared to the stable tantalum monobloc.
Theoretically tantalum should allow a more optimal coating for bone ingrowth, but as primary stability is also important for longterm prostheses survival the method of primary fixation could alså play a role.
To evaluate both the plateau-bone micromotions and the polyethylene-prosthesis micromovements metal markers have been placed on the prosthesis pre-operatively and furthermore into the tibial bone and into the tibial polyethylene during surgery allowing us to evaluate stereo x-rays by a photogrammetric analyses called RSA at the Orthopaedic Center, Aarhus University Hospital. Follow-up stereo x-rays will be scheduled for 1 week, 3 months, 6 month, 1 years, 2 years and 5 years post-surgery.
- Conditions
- Osteoarthritis
- Being tested
- Tibial component
- Keywords
- RSA, Genoarthrosis, Knee arthroplasty, Micromotion of polyethylene liner
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial componentDevice
Also called NexGen Tantalum Tibial Plate, NexGen Titanium Tibial Plate, screw fixed
Tibial component inserted at the time of surgery
| Study group | Role | What they receive |
|---|---|---|
| Tantalum knee | Active comparator | Tantalum Tibial component, uncemented Receives: Device: Tibial component |
| Titanium Knee | Active comparator | Titanium Tibial Component, screw fixed Receives: Device: Tibial component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyethylene wear (mm) of the medial and lateral knee prosthesis compartments at 5 years followup measured with model-based radiostereometry
Measured: Up to 5 years
Secondary outcomes (3)
Difference in MPTM (mm) tibial component migration from 2-5 years (stabilization 3) measured with model-based radiostereometry
Measured: up to 5 years
Number of implants migrating above 0.2mm MTPM from 1-2 years (stabilization 2) and 2-5 years (stabilization 3) measured with model-based radiostereometry
Measured: Up to 5 years
Osteolysis (radiolucent lines >1 mm) in the tibial periprosthetic region measured on radiographs
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startNov 2003
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Kjeld Søballe, MD, Prof., Principal investigator, Orthopaedic Center, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138853
- Sponsor's protocol ID
- 20030119
- Acronym
- Ti-Tan
- Status last verified
- Feb 2020
- First submitted
- 29 Aug 2005
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Roentgen Stereophotogrammetric Analysis on Migration of Knee Prostheses. A Randomised Prospective Study of Tantalum Versus Titanium Implants.
- ClinicalTrials.gov ID
- NCT00138853
- Acronym / sponsor ID
- Ti-Tan / 20030119
- Conditions
- Osteoarthritis
- Keywords
- RSA, Genoarthrosis, Knee arthroplasty, Micromotion of polyethylene liner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Zimmer Biomet
- Study start
- Nov 2003
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 30 Aug 2005 (estimated)
- 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 purpose of this study is to compare the early migration of two uncemented total knee arthroplasties with different metal coating. Only the tibial prosthesis plateau varies. One is made out of tantalum and has two short pegs for fixation into the tibia while the other is covered by titanium fiber-mesh on the bone-near site and has 4 short pegs for screw fixation into the tibia.
Detailed description
Around 4% of total knee arthroplasties (TKA) are revised 15 years after the primary operation, most due to loosening of the implant. The use of uncemented prostheses are expected to extend the fixation time and thereby the years of TKA survival. When a cementless implant is inserted, direct bone ingrowth to the implant depends on a complete primary stabilisation. Movement between the bone and implant will cause a fibrous membrane leading to micromotions. Micromotions can be evaluated by radiophotogrammetric analysis (RSA) in early follow-up and they have been shown to be a prognostic marker for painful loosening of the implant.
Tantalum is a fairly new biomaterial designed with a high and bone-binding porosity. Tantalum has already proven to be a good prosthesis material facilitating fast bone-ingrowth and supplying mechanical qualities in the bone-prosthesis interface that surpasses the qualities of regular prosthesis materials by uncemented method. Titanium on the other hand has been used as a prosthesis coating for years and also promote prosthesis fixation by osteointegration.
The purpose of this study is to compare the early migration of two uncemented total knee implants with different metal coating and fixation method. Only the tibial prosthesis plateau varies in design. One plateau is a 2 pegged tantalum monobloc and the other plateau is a modular titanium fiber-mesh coating with 4 short pegs for screw fixation into the tibia.
Furthermore the extend of the expected micromovements between the polyethylene liner and the metal backing of the titanium plateau will be compared to the stable tantalum monobloc.
Theoretically tantalum should allow a more optimal coating for bone ingrowth, but as primary stability is also important for longterm prostheses survival the method of primary fixation could alså play a role.
To evaluate both the plateau-bone micromotions and the polyethylene-prosthesis micromovements metal markers have been placed on the prosthesis pre-operatively and furthermore into the tibial bone and into the tibial polyethylene during surgery allowing us to evaluate stereo x-rays by a photogrammetric analyses called RSA at the Orthopaedic Center, Aarhus University Hospital. Follow-up stereo x-rays will be scheduled for 1 week, 3 months, 6 month, 1 years, 2 years and 5 years post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tantalum knee | Active comparator | Device: Tibial componentTantalum Tibial component, uncemented |
| Titanium Knee | Active comparator | Device: Tibial componentTitanium Tibial Component, screw fixed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with one- or double-sided primary knee arthrosis.
- Patients with a sufficient bone quality for implantation of an uncemented prosthesis.
- Informed and written patient consent.
Key exclusion criteria (6 listed)
- Patients with neuromuscular or vascular diseases in the affected leg.
- Patients who peroperatively are estimated unsuitable for an uncemented knee arthroplasty e.g. due to bone cysts or dilution of the bone mass.
- Patients who use non-steroid anti-inflammatory drugs (NSAID) and cannot refrain from taking them postoperatively (this includes COX-2-inhibitors).
- Patients with osteoporosis estimated from the preoperative x-ray or former diagnosis of osteoporosis.
- Patients with fracture sequelae.
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 |
|---|---|---|
| Tibial componentAlso: NexGen Tantalum Tibial Plate, NexGen Titanium Tibial Plate, screw fixedTibial component inserted at the time of surgery | Device | Tantalum knee, Titanium Knee |
Primary outcome
Polyethylene wear (mm) of the medial and lateral knee prosthesis compartments at 5 years followup measured with model-based radiostereometry
Time frame: Up to 5 years
3 secondary outcomes
Difference in MPTM (mm) tibial component migration from 2-5 years (stabilization 3) measured with model-based radiostereometry
Time frame: up to 5 years
Number of implants migrating above 0.2mm MTPM from 1-2 years (stabilization 2) and 2-5 years (stabilization 3) measured with model-based radiostereometry
Time frame: Up to 5 years
Osteolysis (radiolucent lines >1 mm) in the tibial periprosthetic region measured on radiographs
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
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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. This study is not recruiting at the moment.
Kjeld Søballe, MD, Prof. principal investigator
Orthopaedic Center, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibial component in people with Osteoarthritis, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyethylene wear (mm) of the medial and lateral knee prosthesis compartments at 5 years followup measured with model-based radiostereometry (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2022.