Study of an All Polyethylene Tibial Component

Knee Replacement Clinical Trial

Official title:

A Prospective Study of an All Polyethylene Tibial Component Used in Total Knee Arthroplasty Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02540902
• Other study ID #: Ortho 15-06
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2019

Study information

• Verified date: May 2019
• Source: Golden Jubilee National Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a prospective single cohort investigation of the Columbus all polyethylene tibia (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The aim of the project is to determine post-operative outcome of the all polyethylene tibia up to two years.

Description:

Thirty consecutive TKA patients under the care of two orthopaedic consultants at the Golden Jubilee National Hospital who meet the inclusion/exclusion criteria will be recruited to the study and will be given the all polyethylene tibia. Participants will return for their standard postoperative followup appointments (6 weeks and 1 year post-operatively). In addition to standard care, a bone density scan using dual energy x-ray absorptiometery (DXA) will be done as part of the 6 weeks post-operative follow-up. A second DXA scan will be done at an additional appointment at the hospital between 18 and 24 months post-operatively for a bone density scan which is not part of standard care.

The data which will be analysed will be the results of the bone scan, computer generated data about the range of movement (RoM) and alignment of the operated knee collected as part of the operation, the RoM, clinical outcome and satisfaction data collected at the pre-operative assessment and post-operative followups, pre- and post-operative x-rays, complications, survivorship and surgeon experience of using the all polyethylene tibia. These data will be investigated to see if the all polyethylene tibia has satisfactory outcomes with no adverse effects.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

1. Unilateral TKA

2. Aged 70 year or older

3. BMI < 37.5

4. Suitable to receive the study implant

Exclusion Criteria:

1. Revision of existing knee replacement

2. Previous lower limb replacement

3. Proximal tibial bone defects

4. Diagnosed osteopenia or osteoporosis

5. Unable to give informed consent

6. Unwilling to take part

7. Unable to return to the Golden Jubilee National Hospital for followup appointments

Related Conditions & MeSH terms

• Knee Replacement

Intervention

Device:
• All-polyethylene tibia (Aesculap AG)
Implantation of an all polyethylene tibial component.

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Clydebank	West Dunbartonshire

Sponsors (2)

Lead Sponsor	Collaborator
Golden Jubilee National Hospital	Aesculap AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density	Measure of peri-prosthetic bone mineral density	18 to 24 months post-operatively
Secondary	Intra-operative RoM	Range of movement of the knee joint measured by the navigation computer during surgery	Intra-operative
Secondary	Intra-operative alignment	The leg alignment measured by the navigation computer during surgery.	Intra-operative
Secondary	RoM	Active range of motion of the knee joint	1 year
Secondary	Oxford Knee Score	Clinical outcome measure	1 year
Secondary	EQ-5D	General health measure	1 year
Secondary	Patient satisfaction	Patient satisfaction with surgery (Scale: 0 to 10, 0 = not satisfied, 10 = very satisfied)	1 year
Secondary	Leg alignment	Leg alignment measured from long leg x-rays	1 year
Secondary	Bone condition	Signs of osteolysis from knee x-rays	1 year
Secondary	Complications	Any post-operative complications as a result of surgery, e.g. infection, revision, aseptic loosening.	1 year
Secondary	Implant survivorship	Percentage of implants still in situ over time.	18 to 24 months
Secondary	Surgeon feedback from surgery	Surgeon experience and issues with using all-polyethylene tibia using an un-validated questionnaire.	intra-operative
Secondary	Component position	Migration of the component over time measured from x-rays	1 year
Secondary	Peri-prosthetic lucency	Radiolucent lines (>2mm wide) around the component which may indicate component loosening	1 year