TRabecular Metal Economic and Clinical Knee Trial

NCT04677907 | Recruiting DMC

• 1 other identifier: GN13OR267
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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?

Conditions

Total Knee Replacement; Orthopedics

Keywords

Total Knee Replacements; Orthopedics; Orthopedic devices; Arthroplasty; Uncemented

Outcome Measures

Primary Outcomes (1)

• Change in Oxford Knee Score (Patient reported outcome measure of pain and function)

  Oxford Knee Score is a joint specific 12 question questionnaire related to the pain and function participants believe they are experiencing in their affected knee. A score of 0 indicating high pain and poor function, while a score of 48 is a healthy highly functioning knee joint. Oxford Knee Score will be recorded pre-operatively, at 3 months and 1 year post-operatively. The difference measured at 1 year will be the primary outcome. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments.

  Baseline, 3 months, 1, 2, 5 and 10 years post-operatively

Secondary Outcomes (18)

• Change in costs per quality adjusted life year (QALY) per participant.

  1, 2 and 10 years post-operatively

• Change in operation time (minutes)

  After last intervention is administered

• Change in clinical movement: walking

  Baseline, 3 months, 1, 2 years post-operatively

• Change in clinical movement: standing from sitting

  Baseline, 3 months, 1, 2 years post-operatively

• Change in clinical movement: walking down stairs

  Baseline, 3 months, 1, 2 years post-operatively

Study Arms (2)

Cemented knee replacement

ACTIVE COMPARATOR

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

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

Uncemented knee replacement

EXPERIMENTAL

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

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

Interventions

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

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

Uncemented knee replacement

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

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

Cemented knee replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Zimmer Biomet: collaborator
• University of Strathclyde: collaborator

Study Sites (1)

Dept of Orthopaedics, Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

RECRUITING

Related Publications (10)

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

  PMID: 12008853 BACKGROUND

• 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.

  PMID: 11033545 BACKGROUND

• 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.

  PMID: 10530861 BACKGROUND

• 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.

  PMID: 10220190 BACKGROUND

• 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.

  PMID: 11241337 BACKGROUND

• 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.

  PMID: 19567852 BACKGROUND

• 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.

  PMID: 19043129 BACKGROUND

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

  PMID: 9571079 BACKGROUND

• 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.

  PMID: 1940933 BACKGROUND

• 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.

  PMID: 17673581 BACKGROUND

Related Links

• Scottish Arthroplasty Report 2018
• National Joint Registry for England and Wales Annual Report 2018.
• Hip and knee arthroplasty. Australian National Joint Replacement Registry Annual Report 2018
• Swedish knee arthroplasty register Annual Report 2018.
• 2004 Report: Total hip and knee replacements in Canada. Canadian Joint replacement Registry (CJRR).

MeSH Terms

Interventions

Prostheses and Implants

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Mark JG Blyth, Mr

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark JG Blyth, Mr

CONTACT

01412114107; mark.blyth@ggc.scot.nhs.uk

James Doonan, Dr

CONTACT

james.doonan@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: all blind except surgeon, who will not take part in study or analysis after surgery
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Double Blinded Randomised Controlled Trial

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: December 21, 2020
• Study Start: May 10, 2022
• Primary Completion: November 30, 2025
• Study Completion (Estimated): June 30, 2035
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)