Constraint choice in revision knee arthroplasty: study protocol of a randomised controlled trial assessing the effect of level of constraint on postoperative outcome

Phase 4

Conditions: M17
Z96
Gonarthrosis [arthrosis of knee]
Presence of other functional implants

Registration Number: DRKS00010539

Lead Sponsor: KH MOL GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 170

Inclusion Criteria

Indications are:
- Rheumatoid arthritis
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result
- Failed osteotomies, unicompartmental replacement, or total knee replacement
In addition, the patient has to fulfil the following criteria to be eligible for the study:
- The patient is scheduled for elective primary or revision knee arthroplasty
- The patient is 18 years or older. There are no upper age limits for the study, as long as the patient is healthy enough to undergo surgery
- The patient is willing to provide informed consent

Exclusion Criteria

- The patient participates in another concurrent study
- Major psychiatric disease
- Patients who do not comprehend the German language (read and speak)
- Pregnancy, lactation, or childbearing potential without using adequate contraception
- Acute or chronic infections, local or systemic (or corresponding previous incidents)
- Severe muscle, nerve, or vascular diseases that endanger the extremity in question
- Lacking bone substance or possessing inadequate bone quality that endangers a stable seating of the prosthesis
- Extreme insufficiency of the knee extensor mechanism
- Adipositas permagna
- Local tumours
- Known hypersensitivity to the material

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative functional outcome as measured by the Knee Injury and Osteoarthritis Outcome Score

Secondary Outcome Measures

Name	Time	Method
Postoperative joint awareness during various activities of daily living as measured by the Forgotten Joint Score-12, the Knee Society Score, along with the incidence and location of radiolucent lines using the Knee Society Total Knee Arthroplasty Radiographic Evaluation System.