NCT01030848

Brief Summary

The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2003

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2009

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

4.6 years

First QC Date

December 11, 2009

Last Update Submit

December 14, 2009

Conditions

OsteoarthritisTotal Knee Replacement

Outcome Measures

Primary Outcomes (1)

  • Knee injury and Osteoarthritis Outcome Score

    Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively

Secondary Outcomes (2)

  • Range of Motion (ROM)

    Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively

  • Knee injury and Osteoarthritis Outcome Score

    10 years postoperatively

Study Arms (1)

Patients with knee osteoarthritis

Device: Total Knee Replacement (LCS rotating platform)

Interventions

Total Knee Replacement (LCS rotating platform)DEVICE
Patients with knee osteoarthritis

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital

You may qualify if:

  • patients with knee osteoarthritis
  • admitted for total knee replacement
  • no rheumatoid arthritis
  • no previous knee infection
  • age 40-85 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martina Hansens Hospital

Bærum, Bærum, 1306, Norway

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Tor Kjetil Nerhus, MD

    Martina Hansens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2009

First Posted

December 14, 2009

Study Start

February 1, 2003

Primary Completion

September 1, 2007

Study Completion

September 1, 2013

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

NO(1)