Patellar Resurfacing in Total Knee Arthroplasty

NCT00553982 | Completed

• 3 other identifiers: aue140-07172b 1.2007.952 (REK)13-2007 SI (Personvernombudet)
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The implantation of a patellar component adds to the operation time and the costs of the operation.There is a huge variation as to whether the patella is resurfaced or not during TKA. Meta-analysis of prospective, randomised trials might indicate that patellar resurfacing reduces the risk of reoperation and anterior knee pain, but drawing firm conclusions is not possible and additional, high quality randomised trials are required. Purpose: The aim of this study is to determine whether ther is a difference between the two groups in knee pain, functions, patient satisfaction and quality of life after TKA.

Conditions

Osteoarthritis; Pain

Keywords

Replacement; Knee; Patella; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Knee injury and Osteoarthritis Outcome Score

  3 years follow up

Secondary Outcomes (1)

• Oxford score, Knee Society score, Stair climbing test, Pain (VAS), Patient satisfaction (VAS)

  3 years follow up

Study Arms (2)

1

EXPERIMENTAL

Patellar resurfacing

Procedure: Patellar component

2

ACTIVE COMPARATOR

Patellar retention

Procedure: No patellar component

Interventions

Patellar component PROCEDURE

Resurfacing with onlay technique

1

No patellar component PROCEDURE

Trimming of osteophytes when appropriate

2

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients less than 85 years old with osteoarthritis scheduled for primary knee arthroplasty.

You may not qualify if:

• Patients who are not able to cooperate
• Serious deformity (not suitable for a standard CR prosthesis)
• Patellar thickness less than 18 mm
• Prior operation involving the extensor mechanism
• Rheumatoid arthritis
• Severe medical disability limiting the ability to walk
• Revision surgery
• Knees with predominantly patellofemoral arthrosis

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead

Study Sites (1)

Sykehuset Innlandet HF, Lillehammer

Lillehammer, 2629, Norway

Location

MeSH Terms

Conditions

Osteoarthritis; Pain; Patella Fracture

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Knee Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Eirik Aunan, Doctor

  Sykehuset Innlandet, Lillehammer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 6, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

NO (1)