All ligaments left In knee arthroplasty trial

Not Applicable

• Conditions: Specialty: Musculoskeletal disorders, Primary sub-specialty: Elective Orthopaedic Surgery; UKCRC code/ Disease: Musculoskeletal/ Other joint disorders; Musculoskeletal Diseases; Musculoskeletal/ Other joint disorders

• Registration Number: ISRCTN12584521
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-14
• Last Update Posted: 1 February 2021
• Study Completion: 2022-02-19

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Primary Osteoarthritis of the knee involving one or more compartments of the joint
2. Intact Anterior and Posterior Cruciate Ligaments
3. Intact collateral ligaments
4. Correctable coronal deformity
5. No more than 15 degrees of fixed flexion deformity

Exclusion Criteria

1. Age under 18 years.
2. Revision knee replacement surgery
3. Rheumatoid Arthritis
4. Traumatic aetiology
5. History or clinical signs of ACL rupture
6. Previous arthroscopy related to ACL injury or reconstruction.
7. Correction of a flexion contracture that may require extensive resection of distal femur
8. Altered pain perception and / or neurologic affection due to diabetes.
9. Contraindications for the knee implant:
9.1. Cementless application of components*
9.2. BMI =40 kg/m2 *
9.3. Use of Anterior Stabilized Bearings*
9.4. Patients with severe pre-operative varus or valgus deformity = 15 degrees*
9.5. Correction or revision of previous joint replacement procedure on index knee*
9.6. Infection
9.7. Sepsis
9.8. Osteomyelitis
9.9. Osteoporosis (requiring treatment)
10. Relative contraindications include:
10.1. Unco-operative patient or patient with neurologic disorders who is incapable of following directions
10.2. Osteoporosis
10.3. Metabolic disorders which may impair bone formation,
10.4. Osteomalacia
10.5. Distant foci of infections which may spread to the implant site
10.6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
10.7. Vascular insufficiency, muscular atrophy, neuromuscular disease
10.8. Incomplete or deficient soft tissue surrounding the knee, including the anterior cruciate ligament*

Study & Design

• Study Type: Interventional
• Study Design: Not specified