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Fluoroscopic Analysis of PFC CR 150 Versus Standard PFC CR Total Knee Arthroplasty Implants in Deep Flexion

NCT ID: NCT01659229

Last Updated: 2012-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-12-31

Brief Summary

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The investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee system designed to combine function with wear resistance. It can accommodate up to 150 degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which can accommodate up to 120 degrees of flexion.

Detailed Description

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Both sets of patients will undergo routine post-operative follow up in clinic. The study involves patients who had their surgery more than 2 years ago. We assess their range of movement using fluoroscopy. They are asked to perform lunges, squats and climbing up and down 3 steps. The fluoroscopic images are then analysed to assess their individual range of movements.

Conditions

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Knee Osteoarthritis

Keywords

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knee osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PFC CR 150 total knee implant

Study group implant: PFC CR 150 Control group implant: PFC CR standard

No interventions assigned to this group

PFC CR Standard

study group implant: PFC CR 150 control group implant: PFC CR Standard

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant
* Surgery more than 2 years
* Able to walk, climb stairs

Exclusion Criteria

* Knee stiffness with less than 100 degrees of knee range of movement
* Patients who required revision surgery
* Patients who received an all polyethylene tibial insert
* Patients who received rotating platform tibial tray
Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy International

INDUSTRY

Sponsor Role collaborator

Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Seng Jin Yeo, MBBS FRCS

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

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Singapore General Hospital

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

References

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Nicholls RL, Schirm AC, Jeffcote BO, Kuster MS. Tibiofemoral force following total knee arthroplasty: comparison of four prosthesis designs in vitro. J Orthop Res. 2007 Nov;25(11):1506-12. doi: 10.1002/jor.20438.

Reference Type BACKGROUND
PMID: 17568418 (View on PubMed)

Other Identifiers

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63214040

Identifier Type: -

Identifier Source: org_study_id