GonarthritisNCT01696552
Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty
A study testing TKR with Positioning Guides (PSPG) and TKR with Conventional Technique in people with Gonarthritis, run by Oslo University Hospital at 4 sites in Norway.
Trial summary
A Prospective, randomized, clinical controlled study comparing conventional knee arthroplasty and the Patient-specific positioning guides (PSPG) (Signature Patient Care, Materialise) using the Vanguard Total Knee System (Biomet) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonarthritis
- What is being tested?
- TKR with Positioning Guides (PSPG) and TKR with Conventional Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 4 sitesNorway
- Study dates
- Sep 2011to Jan 2024
- 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
- Man and women elder than 18 years old with knee osteoarthritis
- Informed consent
Who cannot join
- Active infection.
- Under 50 years.
- Revision arthroplasty.
- Marked bone loss which could preclude adequate fixation of the device.
- Non-cooperative subjects.
- Parkinson's Disease or other neurologic and muscular disorders
Show all 13Show fewer
- Severe vascular insufficiency of the affected limb.
- Severe instability or deformity of the ligaments and / or surrounding soft tissue which may preclude stability of the device.
- Paget's disease
- Rheumatoid Arthritis and other systemic diseases
- Patients with rigid hip joints
- Known metal allergy
- Patients can only join the study with 1 operated knee arthroplasty
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Vestre Viken HF
Drammen, Buskerud, 3004
Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital
Oslo, Olso, 0407
Sykehuset Telemark
Skien, Telemark, 3710
Betanien Hospital Skien
Skien, Telemark, 3722
About this study
Official title: Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.
A Prospective, randomized, clinical controlled study comparing conventional knee arthroplasty and the Patient-specific positioning guides (PSPG) (Signature Patient Care, Materialise) using the Vanguard Total Knee System (Biomet)
Read the detailed description
Background: Use of PSPG in TKR is a relative new technique and already widely used. PSPG, based on MRI data, fit directly into the patient's anatomy and enable total knee replacement without use of traditional invasive instrumentation. Data showing extra benefit of this technique compared to conventional TKR technique are not widely available.
Aim: To determine the safety of this new surgical technique compared to conventional TKR and whether a clinical, functional and financial benefit can be achieved.
Methods: 200 patients with primary osteoarthritis will be randomized to 2 groups. 30 patients in each group will be included in the RSA section of the study. Participating hospitals UOS Ullevål, Vestre Viken, Sykehuset Telemark and Betanien Hospital Skien. Inclusion started Aug. 2011. Clinical scoring: KSS, KOOS, EQ-5D and VAS will be examined at inclusion, after 3 months, and at the 1 and 2 year control. RSA before discharge on day 2, 3 months, 1 year, 2 years. RSA images will be sent blinded to CIRRO (Center for Implant and Radiostereometric Research Oslo Orthopaedic Centre, Oslo University Hospital) for image analysis. Standing HKA: preoperatively and after 3 months. X-ray will be taken pre-operatively, postoperative day 3, after 3 months and after 5 and 10 years. CT Perth after 3 months for measuring alignment. A cost-benefit analysis will be performed.
- Conditions
- Gonarthritis
- Being tested
- TKR with Positioning Guides (PSPG), TKR with Conventional Technique
- Keywords
- Gonarthritis, TKR, Conventional, Positioning Guides, PSPG, CT Perth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKR with Positioning Guides (PSPG)Procedure or surgery
Also called Vanguard Total Knee System, Biomet, Signature, Materialise
TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique
TKR with Conventional TechniqueProcedure or surgery
Also called Vanguard Total Knee System, Biomet
TKR (Vanguard Total Knee System, Biomet) with Conventional Technique
| Study group | Role | What they receive |
|---|---|---|
| TKR with Positioning Guides (PSPG) | Active comparator | Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet) Receives: Procedure: TKR with Positioning Guides (PSPG) |
| TKR with Conventional Technique | Active comparator | TKR (Vanguard Total Knee System, Biomet), Conventional Technique Receives: Procedure: TKR with Conventional Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing total knee implant positioning using PSPG compared with the conventional method in TKR
Measurement of knee implant positioning by using the CT Perth protocol
Measured: 3 months
Secondary outcomes (6)
Clinical Functional Result
KOOS (Knee injury and Osteoarthritis Outcome Score), American knee society score, EQ-5D and pain score (NRS) will be registered pre-operatively, after 3 months and after 1 and 2 years. Scores of the 2 groups will be compared.
Measured: 2 yrs
Operating Time
Measured: 1 day
Component Stability
RSA
Measured: 2 yrs
Cost to Benefit from a Health Economic Perspective
Cost-benefit analysis
Measured: 1 year
X-ray analysis
Standing HKA (Hip, Knee, Ankle-long axis images): preoperatively and after 3 months. If there is a extension deficit a X-HKA will be performed 12 months postoperatively.
X-ray front, side and patella 'sky view' will be taken pre-operatively, postoperative day 3, after 5 and 10 years. Alignment and possible osteolytic development will be recorded in both groups.
Measured: 10 yrs
Perioperative Morbidity
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startSep 2011
- Primary completionJan 2014
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for GonarthritisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Betanien Hospital, Sykehuset Telemark, Vestre Viken Hospital Trust
- Responsible party
- Principal investigator, Stephan M Rohrl, Oslo University Hospital
- Investigators
- Stephan M Röhrl, MD, PhD, Principal investigator, Oslo Univerity Hospital, Oslo, NorwayJustin van Leeuwen, MD, Principal investigator, Betanien Hospital Skien, Skien, NorwayBjarne Grøgaard, MD, PhD, Principal investigator, Oslo University HospitalFinnur Snorrason, MD, PhD, Principal investigator, Vestre Viken HF, Drammen Hospital, Drammen, NorwayHilde Apold, MD, PhD, Principal investigator, Sykehuset Telemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696552
- Sponsor's protocol ID
- 2011/7613
- Other IDs
- 2010/2056
- Status last verified
- Mar 2017
- First submitted
- 19 Aug 2012
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.
PubMed 16195075Ritter MA, Faris PM, Keating EM, Meding JB. Postoperative alignment of total knee replacement. Its effect on survival. Clin Orthop Relat Res. 1994 Feb;(299):153-6.
PubMed 8119010Chauhan SK, Clark GW, Lloyd S, Scott RG, Breidahl W, Sikorski JM. Computer-assisted total knee replacement. A controlled cadaver study using a multi-parameter quantitative CT assessment of alignment (the Perth CT Protocol). J Bone Joint Surg Br. 2004 Aug;86(6):818-23. doi: 10.1302/0301-620x.86b6.15456.
PubMed 15330021Klatt BA, Goyal N, Austin MS, Hozack WJ. Custom-fit total knee arthroplasty (OtisKnee) results in malalignment. J Arthroplasty. 2008 Jan;23(1):26-9. doi: 10.1016/j.arth.2007.10.001.
PubMed 18165024Fehring TK, Odum S, Griffin WL, Mason JB, Nadaud M. Early failures in total knee arthroplasty. Clin Orthop Relat Res. 2001 Nov;(392):315-8. doi: 10.1097/00003086-200111000-00041.
PubMed 11716402Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. 2012 Jan;470(1):99-107. doi: 10.1007/s11999-011-1996-6.
PubMed 21809150Karrholm J, Borssen B, Lowenhielm G, Snorrason F. Does early micromotion of femoral stem prostheses matter? 4-7-year stereoradiographic follow-up of 84 cemented prostheses. J Bone Joint Surg Br. 1994 Nov;76(6):912-7.
PubMed 7983118Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.
PubMed 7744919Matziolis G, Krocker D, Weiss U, Tohtz S, Perka C. A prospective, randomized study of computer-assisted and conventional total knee arthroplasty. Three-dimensional evaluation of implant alignment and rotation. J Bone Joint Surg Am. 2007 Feb;89(2):236-43. doi: 10.2106/JBJS.F.00386.
PubMed 17272435Siston RA, Patel JJ, Goodman SB, Delp SL, Giori NJ. The variability of femoral rotational alignment in total knee arthroplasty. J Bone Joint Surg Am. 2005 Oct;87(10):2276-80. doi: 10.2106/JBJS.D.02945.
PubMed 16203894Lutzner J, Krummenauer F, Wolf C, Gunther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553.
PubMed 18669959Weinrauch P, Myers N, Wilkinson M, Dodsworth J, Fitzpatrick P, Whitehouse S. Comparison of early postoperative rehabilitation outcome following total knee arthroplasty using different surgical approaches and instrumentation. J Orthop Surg (Hong Kong). 2006 Apr;14(1):47-52. doi: 10.1177/230949900601400111.
PubMed 16598087Kalairajah Y, Simpson D, Cossey AJ, Verrall GM, Spriggins AJ. Blood loss after total knee replacement: effects of computer-assisted surgery. J Bone Joint Surg Br. 2005 Nov;87(11):1480-2. doi: 10.1302/0301-620X.87B11.16474.
PubMed 16260662Victor J, Van Doninck D, Labey L, Innocenti B, Parizel PM, Bellemans J. How precise can bony landmarks be determined on a CT scan of the knee? Knee. 2009 Oct;16(5):358-65. doi: 10.1016/j.knee.2009.01.001. Epub 2009 Feb 5.
PubMed 19195896Henckel J, Richards R, Lozhkin K, Harris S, Rodriguez y Baena FM, Barrett AR, Cobb JP. Very low-dose computed tomography for planning and outcome measurement in knee replacement. The imperial knee protocol. J Bone Joint Surg Br. 2006 Nov;88(11):1513-8. doi: 10.1302/0301-620X.88B11.17986.
PubMed 17075100
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT01696552
- Acronym / sponsor ID
- 2011/7613
- Conditions
- Gonarthritis
- Keywords
- Gonarthritis, TKR, Conventional, Positioning Guides, PSPG, CT Perth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Betanien Hospital, Sykehuset Telemark, Vestre Viken Hospital Trust
- Study start
- Sep 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2024 (estimated)
- First posted
- 1 Oct 2012 (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.
A Prospective, randomized, clinical controlled study comparing conventional knee arthroplasty and the Patient-specific positioning guides (PSPG) (Signature Patient Care, Materialise) using the Vanguard Total Knee System (Biomet)
Detailed description
Background: Use of PSPG in TKR is a relative new technique and already widely used. PSPG, based on MRI data, fit directly into the patient's anatomy and enable total knee replacement without use of traditional invasive instrumentation. Data showing extra benefit of this technique compared to conventional TKR technique are not widely available.
Aim: To determine the safety of this new surgical technique compared to conventional TKR and whether a clinical, functional and financial benefit can be achieved.
Methods: 200 patients with primary osteoarthritis will be randomized to 2 groups. 30 patients in each group will be included in the RSA section of the study. Participating hospitals UOS Ullevål, Vestre Viken, Sykehuset Telemark and Betanien Hospital Skien. Inclusion started Aug. 2011. Clinical scoring: KSS, KOOS, EQ-5D and VAS will be examined at inclusion, after 3 months, and at the 1 and 2 year control. RSA before discharge on day 2, 3 months, 1 year, 2 years. RSA images will be sent blinded to CIRRO (Center for Implant and Radiostereometric Research Oslo Orthopaedic Centre, Oslo University Hospital) for image analysis. Standing HKA: preoperatively and after 3 months. X-ray will be taken pre-operatively, postoperative day 3, after 3 months and after 5 and 10 years. CT Perth after 3 months for measuring alignment. A cost-benefit analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKR with Positioning Guides (PSPG) | Active comparator | Procedure: TKR with Positioning Guides (PSPG)Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet) |
| TKR with Conventional Technique | Active comparator | Procedure: TKR with Conventional TechniqueTKR (Vanguard Total Knee System, Biomet), Conventional Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Man and women elder than 18 years old with knee osteoarthritis
- Informed consent
Key exclusion criteria (13 listed)
- Active infection.
- Under 50 years.
- Revision arthroplasty.
- Marked bone loss which could preclude adequate fixation of the device.
- Non-cooperative subjects.
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 |
|---|---|---|
| TKR with Positioning Guides (PSPG)Also: Vanguard Total Knee System, Biomet, Signature, MaterialiseTKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique | Procedure or surgery | TKR with Positioning Guides (PSPG) |
| TKR with Conventional TechniqueAlso: Vanguard Total Knee System, BiometTKR (Vanguard Total Knee System, Biomet) with Conventional Technique | Procedure or surgery | TKR with Conventional Technique |
Primary outcome
Assessing total knee implant positioning using PSPG compared with the conventional method in TKR
Time frame: 3 months
Measurement of knee implant positioning by using the CT Perth protocol
6 secondary outcomes
Clinical Functional Result
Time frame: 2 yrs
Operating Time
Time frame: 1 day
Component Stability
Time frame: 2 yrs
Cost to Benefit from a Health Economic Perspective
Time frame: 1 year
X-ray analysis
Time frame: 10 yrs
Perioperative Morbidity
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Background: PubMed 16195075Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.
- Background: PubMed 8119010Ritter MA, Faris PM, Keating EM, Meding JB. Postoperative alignment of total knee replacement. Its effect on survival. Clin Orthop Relat Res. 1994 Feb;(299):153-6.
- Background: PubMed 15330021Chauhan SK, Clark GW, Lloyd S, Scott RG, Breidahl W, Sikorski JM. Computer-assisted total knee replacement. A controlled cadaver study using a multi-parameter quantitative CT assessment of alignment (the Perth CT Protocol). J Bone Joint Surg Br. 2004 Aug;86(6):818-23. doi: 10.1302/0301-620x.86b6.15456.
- Background: PubMed 18165024Klatt BA, Goyal N, Austin MS, Hozack WJ. Custom-fit total knee arthroplasty (OtisKnee) results in malalignment. J Arthroplasty. 2008 Jan;23(1):26-9. doi: 10.1016/j.arth.2007.10.001.
- Background: PubMed 11716402Fehring TK, Odum S, Griffin WL, Mason JB, Nadaud M. Early failures in total knee arthroplasty. Clin Orthop Relat Res. 2001 Nov;(392):315-8. doi: 10.1097/00003086-200111000-00041.
- Background: PubMed 21809150Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. 2012 Jan;470(1):99-107. doi: 10.1007/s11999-011-1996-6.
- Background: PubMed 7983118Karrholm J, Borssen B, Lowenhielm G, Snorrason F. Does early micromotion of femoral stem prostheses matter? 4-7-year stereoradiographic follow-up of 84 cemented prostheses. J Bone Joint Surg Br. 1994 Nov;76(6):912-7.
- Background: PubMed 7744919Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.
- Background: PubMed 17272435Matziolis G, Krocker D, Weiss U, Tohtz S, Perka C. A prospective, randomized study of computer-assisted and conventional total knee arthroplasty. Three-dimensional evaluation of implant alignment and rotation. J Bone Joint Surg Am. 2007 Feb;89(2):236-43. doi: 10.2106/JBJS.F.00386.
- Background: PubMed 16203894Siston RA, Patel JJ, Goodman SB, Delp SL, Giori NJ. The variability of femoral rotational alignment in total knee arthroplasty. J Bone Joint Surg Am. 2005 Oct;87(10):2276-80. doi: 10.2106/JBJS.D.02945.
- Background: PubMed 18669959Lutzner J, Krummenauer F, Wolf C, Gunther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553.
- Background: PubMed 16598087Weinrauch P, Myers N, Wilkinson M, Dodsworth J, Fitzpatrick P, Whitehouse S. Comparison of early postoperative rehabilitation outcome following total knee arthroplasty using different surgical approaches and instrumentation. J Orthop Surg (Hong Kong). 2006 Apr;14(1):47-52. doi: 10.1177/230949900601400111.
- Study description on website: Center for Implant and Radiostereometric Research Oslo - Oslo University HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Stephan M Röhrl, MD, PhD principal investigator
Oslo Univerity Hospital, Oslo, Norway
Justin van Leeuwen, MD principal investigator
Betanien Hospital Skien, Skien, Norway
Bjarne Grøgaard, MD, PhD principal investigator
Oslo University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TKR with Positioning Guides (PSPG) and TKR with Conventional Technique in people with Gonarthritis, run by Oslo University Hospital at 4 sites in Norway.
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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. 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?
Results are not available in the source record.
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?
Assessing total knee implant positioning using PSPG compared with the conventional method in TKR (time frame: 3 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 NCT01696552, which also lists 16 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 29 Mar 2017; AzTrials last refreshed its copy on 4 Nov 2026.