Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Oslo University Hospital
Sponsor:
Collaborators:
Betanien Hospital
Sykehuset Telemark
Vestre Viken Hospital Trust
Information provided by (Responsible Party):
Stephan M Rohrl, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01696552
First received: August 19, 2012
Last updated: September 27, 2012
Last verified: September 2012
  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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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:
  • Vanguard Total Knee System, Biomet
  • Signature, Materialise
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
Criteria

Inclusion Criteria:

  1. Man and women elder than 18 years old with knee osteoarthritis
  2. Informed consent

Exclusion Criteria:

  1. Active infection.
  2. Under 50 years.
  3. Revision arthroplasty.
  4. Marked bone loss which could preclude adequate fixation of the device.
  5. Non-cooperative subjects.
  6. Parkinson's Disease or other neurologic and muscular disorders
  7. Severe vascular insufficiency of the affected limb.
  8. Severe instability or deformity of the ligaments and / or surrounding soft tissue which may preclude stability of the device.
  9. Paget's disease
  10. Rheumatoid Arthritis and other systemic diseases
  11. Patients with rigid hip joints
  12. Known metal allergy
  13. Patients can only join the study with 1 operated knee arthroplasty
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696552

Contacts
Contact: Stephan M Röhrl, MD, PhD +47-91502770 s.m.rohrl@medisin.uio.no
Contact: Justin van Leeuwen, MD +47-47337863 jamjvanleeuwen@gmail.com

Locations
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         
Sponsors and Collaborators
Oslo University Hospital
Betanien Hospital
Sykehuset Telemark
Vestre Viken Hospital Trust
Investigators
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:
Cimetidine
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H2 Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014