TRabecular Metal Economic and Clinical Knee Trial

NCT ID: NCT04677907

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2035-06-30

Brief Summary

To compare the differences, if any, in clinical outcome, patient satisfaction and survivorship between cemented and uncemented Total Knee Replacements (TKR)? To investigate if there are health economic implications of using uncemented TKRs in the NHS?

Detailed Description

The investigators propose to undertake a randomised controlled trial comparing Trabecular metal uncemented TKR with cemented TKR. The primary aim will be to determine whether there is a clinically significant difference in outcome between cemented and uncemented knee prosthesis over a 10-year period. The investigators will assess the patient's functional ability using two clinical knee scores the New Knee Society Score (NKSS) and Oxford knee score (OKS). In addition to employing these two standard clinical scores, the investigators will also utilise the Forgotten Joint Score (FJS). The FJS differentiates patients' awareness of the participant's artificial joint which is an important concept in knee arthroplasty. In contrast to hip arthroplasty where the majority of patients are unaware of their joint after surgery, knee arthroplasty patients rarely 'forget' that their joint is artificial. Given the difference in physical properties of trabecular metal and standard implants, the FJS scoring system may highlight potential differences that are important to patients and linked to patient satisfaction. Non-subjective assessment will be performed using Inertial Measuring Units (IMU), which measure the relative position of limbs in space and is a useful measure for clinical movement analysis. Participants will be asked to perform daily task such as walking, standing from a chair and walking up and down stairs, wearing the IMU, before and after surgery. This allows us to see functional improvements after surgery and if there are functional differences between the cemented and uncemented implant.

Clinical evaluation and radiological assessment will be carried out over a 10-year period recording complications and clinical performance of patients and implants.

In addition to carrying out a clinical evaluation of the trabecular metal uncemented knee and cemented knee systems, the investigators will also undertake a health economic assessment of the benefits of using uncemented trabecular metal prostheses.

The most expensive resources in a hospital theatre environment are the surgeon and anaesthetist and maximising their utilisation is essential. The removal of cement mixing and curing time from a TKR offers a potential time saving during the operation. However, the time saved using an uncemented prosthesis during a single operation is unlikely, in isolation, to be sufficient to allow additional clinical activity to be carried out. Nevertheless, by combining multiple uncemented knee replacement operations in a single theatre session it may be possible to save sufficient time during the entire day to facilitate an additional surgical procedure, thus increasing the utilisation of surgeons, anaesthetists and theatre staff. If this were achievable, it would add significant value for health care providers.

Despite the success of knee arthroplasty 18% of patients are dissatisfied with their outcome [16]. These are an important group of patients and understanding better the issues that these patients encounter is key in achieving better satisfaction rates and ensuring appropriate use of Orthopaedic implants. The investigators will therefore also study patient factors such as depression and ability to deal with pain/discomfort and correlate these with post-surgical outcome.

Trabecular metal uncemented implants potentially offer benefits to both patient and surgeon but as yet there is insufficient data available to support widespread use of this product. It is the investigators belief that uncemented knees are underutilised by surgeons because there are a number of areas of concern which have not been adequately addressed in clinical studies. The investigators hope to address these concerns in this study.

Conditions

Total Knee Replacement; Orthopedics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Cemented knee replacement

total knee replacement with cemented modular knee replacement as per current standard for total knee replacements.

Group Type: ACTIVE_COMPARATOR

Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis

Intervention Type: DEVICE

Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis

Uncemented knee replacement

total knee replacement with uncemented modular knee replacement, which is CE certified and accepted in the field.

Group Type: EXPERIMENTAL

Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis

Intervention Type: DEVICE

Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis

Interventions

Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis

Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis

Intervention Type: DEVICE

Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis

Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female subjects may be recruited to the evaluation.
• Age - there are no restrictions relating to age of the patient.
• Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
• Subjects who in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigation procedures and are willing to return to the hospital for all the required post-operative follow-ups.
• Subjects with uni-lateral osteoarthritis of the knee or subjects with bi-lateral osteoarthritis of the knee, who have a well functioning and pain free knee replacement in the contralateral knee.
• Subjects who require a TKR for surgical management of osteoarthritis

Exclusion Criteria

• Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in the study.
• Patients with bi-lateral disease that significantly impacts on their current function and pain.
• Patients who require revision knee arthroplasty surgery.
• Disorders of the feet, ankles, hips or spine causing significant abnormal gait or significant pain.
• Neurological conditions affecting movement.
• Patients with a pathology, which, in the opinion of the Chief Investigator, will adversely affect healing.
• Patients with other disorders which, in the opinion of the Chief Investigator, will/could impair rehabilitation.
• Subjects who in the opinion of the study investigator are unlikely to comply with the study follow-up protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

University of Strathclyde

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark JG Blyth, Mr

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Locations

Dept of Orthopaedics, Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Mark JG Blyth, Mr

Role: CONTACT

mark.blyth@ggc.scot.nhs.uk

01412114107

James Doonan, Dr

Role: CONTACT

james.doonan@glasgow.ac.uk

Facility Contacts

Mark JG Blyth, Mr

Role: primary

mark.blyth@ggc.scot.nhs.uk

James Doonan, PhD

Role: backup

james.doonan@glasgow.ac.uk

References

Cohen R. A porous tantalum trabecular metal: basic science. Am J Orthop (Belle Mead NJ). 2002 Apr;31(4):216-7.

Reference Type: BACKGROUND

PMID: 12008853 (View on PubMed)

Hacking SA, Bobyn JD, Toh K, Tanzer M, Krygier JJ. Fibrous tissue ingrowth and attachment to porous tantalum. J Biomed Mater Res. 2000 Dec 15;52(4):631-8. doi: 10.1002/1097-4636(20001215)52:43.0.co;2-6.

Reference Type: BACKGROUND

PMID: 11033545 (View on PubMed)

Bobyn JD, Stackpool GJ, Hacking SA, Tanzer M, Krygier JJ. Characteristics of bone ingrowth and interface mechanics of a new porous tantalum biomaterial. J Bone Joint Surg Br. 1999 Sep;81(5):907-14. doi: 10.1302/0301-620x.81b5.9283.

Reference Type: BACKGROUND

PMID: 10530861 (View on PubMed)

Bobyn JD, Toh KK, Hacking SA, Tanzer M, Krygier JJ. Tissue response to porous tantalum acetabular cups: a canine model. J Arthroplasty. 1999 Apr;14(3):347-54. doi: 10.1016/s0883-5403(99)90062-1.

Reference Type: BACKGROUND

PMID: 10220190 (View on PubMed)

Zardiackas LD, Parsell DE, Dillon LD, Mitchell DW, Nunnery LA, Poggie R. Structure, metallurgy, and mechanical properties of a porous tantalum foam. J Biomed Mater Res. 2001;58(2):180-7. doi: 10.1002/1097-4636(2001)58:23.0.co;2-5.

Reference Type: BACKGROUND

PMID: 11241337 (View on PubMed)

Gandhi R, Tsvetkov D, Davey JR, Mahomed NN. Survival and clinical function of cemented and uncemented prostheses in total knee replacement: a meta-analysis. J Bone Joint Surg Br. 2009 Jul;91(7):889-95. doi: 10.1302/0301-620X.91B7.21702.

Reference Type: BACKGROUND

PMID: 19567852 (View on PubMed)

Henricson A, Linder L, Nilsson KG. A trabecular metal tibial component in total knee replacement in patients younger than 60 years: a two-year radiostereophotogrammetric analysis. J Bone Joint Surg Br. 2008 Dec;90(12):1585-93. doi: 10.1302/0301-620X.90B12.20797.

Reference Type: BACKGROUND

PMID: 19043129 (View on PubMed)

European Training Program in Microseparation Techniques. Methods. 1998 Feb;14(2):235.

Reference Type: BACKGROUND

PMID: 9571079 (View on PubMed)

Nilsson KG, Karrholm J, Ekelund L, Magnusson P. Evaluation of micromotion in cemented vs uncemented knee arthroplasty in osteoarthrosis and rheumatoid arthritis. Randomized study using roentgen stereophotogrammetric analysis. J Arthroplasty. 1991 Sep;6(3):265-78. doi: 10.1016/s0883-5403(06)80174-9.

Reference Type: BACKGROUND

PMID: 1940933 (View on PubMed)

Baker PN, van der Meulen JH, Lewsey J, Gregg PJ; National Joint Registry for England and Wales. The role of pain and function in determining patient satisfaction after total knee replacement. Data from the National Joint Registry for England and Wales. J Bone Joint Surg Br. 2007 Jul;89(7):893-900. doi: 10.1302/0301-620X.89B7.19091.

Reference Type: BACKGROUND

PMID: 17673581 (View on PubMed)

Related Links

https://www.arthro.scot.nhs.uk/docs/2018/2018-08-14-SAP-Annual-Report.pdf?1

Scottish Arthroplasty Report 2018

https://www.hqip.org.uk/wp-content/uploads/2018/11/NJR-15th-Annual-Report-2018.pdf

National Joint Registry for England and Wales Annual Report 2018.

https://aoanjrr.sahmri.com/documents/10180/576950/Hip%2C%20Knee%20%26%20Shoulder%20Arthroplasty

Hip and knee arthroplasty. Australian National Joint Replacement Registry Annual Report 2018

http://www.myknee.se/en/

Swedish knee arthroplasty register Annual Report 2018.

http://publications.gc.ca/collections/Collection/H115-7-2004E.pdf

2004 Report: Total hip and knee replacements in Canada. Canadian Joint replacement Registry (CJRR).

Other Identifiers

GN13OR267

Identifier Type: -

Identifier Source: org_study_id