NCT00755144

Brief Summary

This is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

3.8 years

First QC Date

September 17, 2008

Last Update Submit

June 16, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • American Knee Society Score

    Preoperative, 8weeks, 1 year

Secondary Outcomes (2)

  • WOMAC

    preoperative, 8 weeks, 1 year

  • VAS Pain

    Preoperative, 4weeks, 8weeks, 3months, 1 year

Study Arms (2)

1

EXPERIMENTAL

ROCC

Device: ROCC Knee

2

ACTIVE COMPARATOR

LCS

Device: LCS Knee

Interventions

LCS KneeDEVICE

Cementless total knee arthroplasty with LCS Knee

2
ROCC KneeDEVICE

Cementless total knee arthroplasty with ROCC Knee

1

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suitable for cementless knee replacement
  • Patients skeletally mature and under 80 years of age at pre-operative clinic
  • Patients presenting with osteoarthritis of the knee
  • Patients must be ambulatory at time of pre-operative clinic
  • Patients must be able to understand instructions and be will to return for follow-up

You may not qualify if:

  • Previous knee surgery (except arthroscopic/open menisectomy)
  • Patients with inflammatory arthritis
  • Patients with significant medical co-morbidity - ASA IV
  • Disorders causing abnormal gait or significant pain
  • Patients unable to consent
  • Severe visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Musgrave Park Hospital

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

April 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

GB(1)