OsteoarthritisNCT00175188
An RSA and DEXA Study on Migration of Proximal Interphalangeal (PIP) Joint Prostheses of the Hand
A study testing Avanta (PIP joint implant with a titanium porous coating) 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 and the periprosthetic bone changes of cemented versus non-cemented interphalangeal implants using Roentgen stereophotogrammetric analysis and dual energy x-ray absorptiometry (DEXA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Avanta (PIP joint implant with a titanium porous coating)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2004to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthrosis of the PIP joints.
- Patients with sufficient bone quality for implantation of a non-cemented prosthesis. This is estimated by the surgeon preoperatively.
- Informed written patient consent.
- Patients must read and understand Danish.
Who cannot join
- Patients with neuromuscular or vascular diseases in the affected upper extremity.
- Patients who, preoperatively, are found to have unsuitable bone quality for un-cemented arthroplasty fixation, for instance bone cysts not visible on x-ray.
- Patients who cannot refrain from taking non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively including cox-2 inhibitors.
- Patients with previously diagnosed osteoporosis.
- Women who are pregnant or are at risk of getting pregnant during the time of investigation.
- Patients with rheumatoid arthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Roentgen Stereophotogrammetric Analysis and DEXA Study on Migration of Proximal Interphalangeal Joint Prostheses of the Hand. A Randomised Prospective Study of Cemented Versus Non-cemented Implants
The purpose of this study is to compare the early migration and the periprosthetic bone changes of cemented versus non-cemented interphalangeal implants using Roentgen stereophotogrammetric analysis and dual energy x-ray absorptiometry (DEXA). Furthermore, a thorough occupational therapist evaluation on the functional progress prior to and after surgery will be assessed.
Read the detailed description
There is a large patient group with primary osteoarthritis (OA) and secondary osteoarthritis due to joint-associated fractures, repeated trauma to the joint and surroundings, congenital joint-deformity, hyper mobility and diabetes. There are 2 preservative surgical treatment alternatives for PIP joint OA; namely arthrodesis and arthroplasty. Arthroplasty is the choice of treatment, when preserving motion is feasible, but patients can have excellent results with arthrodesis. There are several arthroplasty techniques including fibrous interposition, palmar plate advancement, metallic or metalloplastic hinges or one piece polymeric plastic hinge devices.
In this study, we use a 2 part metallic implant designed to minimize bone removal and preserve the collateral ligaments of the PIP joint providing a more stable joint particularly to imposed lateral forces. Preservation of the capsule with this prosthesis allows diversion of some of the transverse forces and axial torques from the prosthesis endosteal interface to the lateral cortices through the collateral ligaments. The semi-constrained design provides a more physiological articulation, and besides this the centered anatomical configuration allows a more reliable restoration of tendon movements to the joint. All of this probably diminishes the mechanical contribution to osteolysis and subsidence at the bone prosthesis interface and prolongs the time of survival of the prosthesis. All of these improvements on prosthetic design are very important and provide a better possibility for the patient to regain near-normal joint conditions.
The prosthesis has two components - one proximal and one distal. The proximal part has a symmetric shallow bicondylar anatomic configuration fixed on a stem for the intramedullary cavity of the proximal phalanx. The distal component is fabricated from polyethylene press-molded on a metal backing with a stem for the intramedullary cavity of the middle phalanx. Both implant parts are CoCr alloy with a coating of plasma sprayed porous titanium. Studies have shown that bone grows well into the titanium surface of experimental implants, but it is also fixed into bone using cement.
With the new type of PIP prostheses there is often excellent if not total long-term pain relief and little or no loss of movement. The stability becomes considerably better compared with older types of prostheses. The outcome is however dependant on the skill and experience of the surgeon.
The purpose of this study is to compare the early migration and the periprosthetic bone changes of cemented versus non-cemented interphalangeal implants. Furthermore a thorough occupational therapist evaluation on the functional progress prior to and after surgery will be assessed.
To evaluate both the implant-bone micromotions, metal markers have been placed on the implant preoperatively and other markers will be fixed in the phalangeal bone intra-operatively. This allows us to evaluate the implant micromotion with stereo x-rays by photogrammetric computer analyses called RSA at the Orthopaedic Center, Aarhus University Hospital. Follow-up stereo x-rays will be scheduled for 1 week, 6 weeks, 12 weeks, 6 months, 1 year and 2 years post-surgery. Periprosthetic bone density will be evaluated at 1 week, 1 year and 2 years upon inclusion at the Orthopaedic Center, Aarhus University Hospital. An occupational therapist will evaluate the joint range of motion, pain, edema and grip strength prior to surgery and throughout the 2 year follow up.
- Conditions
- Osteoarthritis
- Being tested
- Avanta (PIP joint implant with a titanium porous coating)
- Keywords
- RSA, DEXA, Osteoarthritis, Finger implant, Micromotion, Bone density, Cement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avanta (PIP joint implant with a titanium porous coating)Device
Also called Avanta PIP implant, plasma-spray titanium coated
Implant is inserted at the time of surgery, after written consent
| Study group | Role | What they receive |
|---|---|---|
| Cemented PIP implant | Active comparator | Avanta PIP Receives: Device: Avanta (PIP joint implant with a titanium porous coating) |
| Uncemented PIP implant | Active comparator | Avanta PIP Receives: Device: Avanta (PIP joint implant with a titanium porous coating) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIP implant migration evaluated by RSA
Measured: 2010
Periprosthetic bone changes evaluated by DEXA
Measured: 2010
Secondary outcomes (1)
Changes in pain, grip strength, edema and range of motion
Measured: 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionAug 2010
- Study completionOct 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Zimmer Biomet, Avanta
- Investigators
- Kjeld Søballe, MD, Prof., Principal investigator, Orthopaedic Center, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175188
- Sponsor's protocol ID
- 20030240
- Status last verified
- Oct 2010
- First submitted
- 10 Sep 2005
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Roentgen Stereophotogrammetric Analysis and DEXA Study on Migration of Proximal Interphalangeal Joint Prostheses of the Hand. A Randomised Prospective Study of Cemented Versus Non-cemented Implants
- ClinicalTrials.gov ID
- NCT00175188
- Acronym / sponsor ID
- 20030240
- Conditions
- Osteoarthritis
- Keywords
- RSA, DEXA, Osteoarthritis, Finger implant, Micromotion, Bone density, Cement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Zimmer Biomet, Avanta
- Study start
- Jun 2004
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Sep 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 and the periprosthetic bone changes of cemented versus non-cemented interphalangeal implants using Roentgen stereophotogrammetric analysis and dual energy x-ray absorptiometry (DEXA). Furthermore, a thorough occupational therapist evaluation on the functional progress prior to and after surgery will be assessed.
Detailed description
There is a large patient group with primary osteoarthritis (OA) and secondary osteoarthritis due to joint-associated fractures, repeated trauma to the joint and surroundings, congenital joint-deformity, hyper mobility and diabetes. There are 2 preservative surgical treatment alternatives for PIP joint OA; namely arthrodesis and arthroplasty. Arthroplasty is the choice of treatment, when preserving motion is feasible, but patients can have excellent results with arthrodesis. There are several arthroplasty techniques including fibrous interposition, palmar plate advancement, metallic or metalloplastic hinges or one piece polymeric plastic hinge devices.
In this study, we use a 2 part metallic implant designed to minimize bone removal and preserve the collateral ligaments of the PIP joint providing a more stable joint particularly to imposed lateral forces. Preservation of the capsule with this prosthesis allows diversion of some of the transverse forces and axial torques from the prosthesis endosteal interface to the lateral cortices through the collateral ligaments. The semi-constrained design provides a more physiological articulation, and besides this the centered anatomical configuration allows a more reliable restoration of tendon movements to the joint. All of this probably diminishes the mechanical contribution to osteolysis and subsidence at the bone prosthesis interface and prolongs the time of survival of the prosthesis. All of these improvements on prosthetic design are very important and provide a better possibility for the patient to regain near-normal joint conditions.
The prosthesis has two components - one proximal and one distal. The proximal part has a symmetric shallow bicondylar anatomic configuration fixed on a stem for the intramedullary cavity of the proximal phalanx. The distal component is fabricated from polyethylene press-molded on a metal backing with a stem for the intramedullary cavity of the middle phalanx. Both implant parts are CoCr alloy with a coating of plasma sprayed porous titanium. Studies have shown that bone grows well into the titanium surface of experimental implants, but it is also fixed into bone using cement.
With the new type of PIP prostheses there is often excellent if not total long-term pain relief and little or no loss of movement. The stability becomes considerably better compared with older types of prostheses. The outcome is however dependant on the skill and experience of the surgeon.
The purpose of this study is to compare the early migration and the periprosthetic bone changes of cemented versus non-cemented interphalangeal implants. Furthermore a thorough occupational therapist evaluation on the functional progress prior to and after surgery will be assessed.
To evaluate both the implant-bone micromotions, metal markers have been placed on the implant preoperatively and other markers will be fixed in the phalangeal bone intra-operatively. This allows us to evaluate the implant micromotion with stereo x-rays by photogrammetric computer analyses called RSA at the Orthopaedic Center, Aarhus University Hospital. Follow-up stereo x-rays will be scheduled for 1 week, 6 weeks, 12 weeks, 6 months, 1 year and 2 years post-surgery. Periprosthetic bone density will be evaluated at 1 week, 1 year and 2 years upon inclusion at the Orthopaedic Center, Aarhus University Hospital. An occupational therapist will evaluate the joint range of motion, pain, edema and grip strength prior to surgery and throughout the 2 year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented PIP implant | Active comparator | Device: Avanta (PIP joint implant with a titanium porous coating)Avanta PIP |
| Uncemented PIP implant | Active comparator | Device: Avanta (PIP joint implant with a titanium porous coating)Avanta PIP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with osteoarthrosis of the PIP joints.
- Patients with sufficient bone quality for implantation of a non-cemented prosthesis. This is estimated by the surgeon preoperatively.
- Informed written patient consent.
- Patients must read and understand Danish.
Key exclusion criteria (6 listed)
- Patients with neuromuscular or vascular diseases in the affected upper extremity.
- Patients who, preoperatively, are found to have unsuitable bone quality for un-cemented arthroplasty fixation, for instance bone cysts not visible on x-ray.
- Patients who cannot refrain from taking non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively including cox-2 inhibitors.
- Patients with previously diagnosed osteoporosis.
- Women who are pregnant or are at risk of getting pregnant during the time of investigation.
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 |
|---|---|---|
| Avanta (PIP joint implant with a titanium porous coating)Also: Avanta PIP implant, plasma-spray titanium coatedImplant is inserted at the time of surgery, after written consent | Device | Cemented PIP implant, Uncemented PIP implant |
Primary outcome
PIP implant migration evaluated by RSA
Time frame: 2010
Periprosthetic bone changes evaluated by DEXA
Time frame: 2010
1 secondary outcome
Changes in pain, grip strength, edema and range of motion
Time frame: 2010
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 13 Oct 2010.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avanta (PIP joint implant with a titanium porous coating) 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 4 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 13 Oct 2010. 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?
PIP implant migration evaluated by RSA (time frame: 2010). The study lists 2 primary outcomes in all. 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 13 Oct 2010.