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

Not Applicable

• Conditions: Gonarthritis
• Interventions: Procedure: TKR with Positioning Guides (PSPG); Procedure: TKR with Conventional Technique

• Registration Number: NCT01696552
• Lead Sponsor: Oslo University Hospital

Brief 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)

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-08-19
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-01
• Primary Completion: 2014-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TKR with Positioning Guides (PSPG)	TKR with Positioning Guides (PSPG)	Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet)
TKR with Conventional Technique	TKR with Conventional Technique	TKR (Vanguard Total Knee System, Biomet), Conventional Technique

Primary Outcome Measures

Name	Time	Method
Assessing total knee implant positioning using PSPG compared with the conventional method in TKR	3 months	Measurement of knee implant positioning by using the CT Perth protocol

Secondary Outcome Measures

Name	Time	Method
Clinical Functional Result	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	1 day
Component Stability	2 yrs	RSA
Cost to Benefit from a Health Economic Perspective	1 year	Cost-benefit analysis
X-ray analysis	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	1 week

Trial Locations

Locations (4)

Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital; 🇳🇴 Oslo, Olso, Norway

Sykehuset Telemark; 🇳🇴 Skien, Telemark, Norway

Vestre Viken HF; 🇳🇴 Drammen, Buskerud, Norway

Betanien Hospital Skien; 🇳🇴 Skien, Telemark, Norway