Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty
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Purpose
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)
| Condition | Intervention |
|---|---|
|
Gonarthritis |
Procedure: TKR with Positioning Guides (PSPG) Procedure: TKR with Conventional Technique |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study. |
- Assessing total knee implant positioning using PSPG compared with the conventional method in TKR [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Measurement of knee implant positioning by using the CT Perth protocol
- Clinical Functional Result [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Component Stability [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]RSA
- Cost to Benefit from a Health Economic Perspective [ Time Frame: 1 year ] [ Designated as safety issue: No ]Cost-benefit analysis
- X-ray analysis [ Time Frame: 10 yrs ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | May 2020 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Names:
|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Man and women elder than 18 years old with knee osteoarthritis
- Informed consent
Exclusion Criteria:
- 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
- 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
Contacts and Locations| Contact: Stephan M Röhrl, MD, PhD | +47-91502770 | s.m.rohrl@medisin.uio.no |
| Contact: Justin van Leeuwen, MD | +47-47337863 | jamjvanleeuwen@gmail.com |
| Norway | |
| Vestre Viken HF | Active, not recruiting |
| Drammen, Buskerud, Norway, 3004 | |
| Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital | Recruiting |
| Oslo, Olso, Norway, 0407 | |
| Contact: Stephan M Röhrl, MD, PhD +47-91502770 s.m.rohrl@medisin.uio.no | |
| Contact: Justin van Leeuwen, MD +47-47337863 jamjvanleeuwen@gmail.com | |
| Principal Investigator: Stephan M Röhrl, MD, PhD | |
| Principal Investigator: Bjarne Grøgaard, MD, PhD | |
| Betanien Hospital Skien | Recruiting |
| Skien, Telemark, Norway, 3722 | |
| Contact: Justin van Leeuwen, MD +47-337863 jamjvanleeuwen@gmail.com | |
| Principal Investigator: Justin van Leeuwen, MD | |
| Sykehuset Telemark | Recruiting |
| Skien, Telemark, Norway, 3710 | |
| Contact: Hilde Apold, MD +47-95877179 hilde.apold@sthf.no | |
| Sub-Investigator: Hilde Apold, MD | |
| 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 | Sykehuset Telemark |
More Information
Additional Information:
Publications:
| Responsible Party: | Stephan M Rohrl, Principal Investigator, Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01696552 History of Changes |
| Other Study ID Numbers: | 2011/7613, 2010/2056 |
| Study First Received: | August 19, 2012 |
| Last Updated: | September 27, 2012 |
| Health Authority: | Norway: Regional Ethics Commitee |
Keywords provided by Oslo University Hospital:
|
Gonarthritis TKR Conventional |
Positioning Guides PSPG CT Perth |
Additional relevant MeSH terms:
|
Arthritis Joint Diseases Musculoskeletal Diseases Cimetidine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Histamine H2 Antagonists |
Histamine Antagonists Histamine Agents Neurotransmitter Agents Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013