Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty
|ClinicalTrials.gov Identifier: NCT01696552|
Recruitment Status : Active, not recruiting
First Posted : October 1, 2012
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gonarthritis||Procedure: TKR with Positioning Guides (PSPG) Procedure: TKR with Conventional Technique||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2024|
Active Comparator: TKR with Positioning Guides (PSPG)
Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet)
Procedure: TKR with Positioning Guides (PSPG)
TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique
Active Comparator: TKR with Conventional Technique
TKR (Vanguard Total Knee System, Biomet), Conventional Technique
Procedure: TKR with Conventional Technique
TKR (Vanguard Total Knee System, Biomet) with Conventional Technique
Other Name: Vanguard Total Knee System, Biomet
- 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
- Clinical Functional Result [ Time Frame: 2 yrs ]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.
- Operating Time [ Time Frame: 1 day ]
- Component Stability [ Time Frame: 2 yrs ]RSA
- Cost to Benefit from a Health Economic Perspective [ Time Frame: 1 year ]Cost-benefit analysis
- X-ray analysis [ Time Frame: 10 yrs ]
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.
- Perioperative Morbidity [ Time Frame: 1 week ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696552
|Vestre Viken HF|
|Drammen, Buskerud, Norway, 3004|
|Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital|
|Oslo, Olso, Norway, 0407|
|Skien, Telemark, Norway, 3710|
|Betanien Hospital Skien|
|Skien, Telemark, Norway, 3722|
|Principal Investigator:||Stephan M Röhrl, MD, PhD||Oslo Univerity Hospital, Oslo, Norway|
|Principal Investigator:||Justin van Leeuwen, MD||Betanien Hospital Skien, Skien, Norway|
|Principal Investigator:||Bjarne Grøgaard, MD, PhD||Oslo University Hospital, Oslo, Norway|
|Principal Investigator:||Finnur Snorrason, MD, PhD||Vestre Viken HF, Drammen Hospital, Drammen, Norway|
|Principal Investigator:||Hilde Apold, MD, PhD||Sykehuset Telemark|