Finnish Unicompartmental and Total Knee Arthroplasty Investigation

NCT02481427 | Active Not Recruiting

• 1 other identifier: T127/2015
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

Unicondylar knee arthroplasty (UKA) can be used as the treatment of knee OA isolated to a single compartment instead of TKA. Both UKA and TKA have been used for decades as a treatment of knee OA. However, operative indications for TKA and UKA overlaps, but they are not similar. Therefore, the outcome or survivorship of these procedures cannot be compared directly. Some advantages of UKA over TKA have been reported, including faster recovery time, reduced perioperative morbidity and mortality, a subjective preference of feeling more normal knee, lower cost and improved return to work and sport. On the other side national arthroplasty registers consistently report around a threefold increase in crude cumulative revision rate at 8 to 10 years for UKA compared with TKA 7-10. The aim of this study is to compare functional, clinical, patient satisfaction, and implant survival results of cementless UKA with those of cemented TKA at 2 months, 1, 2, 5 and 10 years after the procedure. The study design is a multicenter, double-blind and randomized trial of knee replacement patients. The primary outcome is the Oxford Knee Score (OKS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 year.

Conditions

Osteoarthritis, Knee

Keywords

Total; Unicondylar; Osteoarthritis; Arthroplasty; Replacement; Knee

Outcome Measures

Primary Outcomes (2)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Questionnaires will be collected also at 2 months, 1 year, 2 year, 5 and 10 years. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). KOOS is responsive to change following non-surgical and surgical interventions 17.

  2 months to 10 years

• Oxford Knee Score (OKS)

  2 months to 10 years

Secondary Outcomes (5)

• 15D

  2 months to 10 years

• Knee Society Score (KSS)

  2 months to 10 years

• Radiographic features including signs of potential failures, including loosening and periprosthetic fracture

  2 months to 10 years

• complications

  2 months to 10 years

• revision rate

  2 months to 10 years

Study Arms (2)

Total Knee Replacement

EXPERIMENTAL

TKA is performed through a standard medial parapatellar incision, which provides easy access to the knee joint. Skin incision is done to midline. Intramedullary guide is used for alignment of femoral and tibia saw cuts and component positions. Components will be cemented in position. The patella will not be resurfaced. Intraoperative local infiltration analgesia (LIA) is used for postoperative pain management. Drain is not used.

Procedure: Total Knee Replacement

Unicondylar Knee Replacement

EXPERIMENTAL

UKA involves only the replacement of affected medial compartment. In the study, the operation will be performed through standard medial parapatellar incision with midline skin incision, but the knee joint and fascia will be opened like in standard Oxford minimally invasive incision. The procedure will be performed by using Oxford Microplasty instrumentation and following Microplasty surgical technique (Biomet Orthopedics). Intraoperative local infiltration analgesia is used for postoperative pain management. Drain is not used.

Procedure: Unicondylar Knee Replacement

Interventions

Unicondylar Knee Replacement PROCEDURE

UKA involves only the replacement of affected medial compartment. In the study, the operation will be performed through standard medial parapatellar incision with midline skin incision, but the knee joint and fascia will be opened like in standard Oxford minimally invasive incision. The procedure will be performed by using Oxford Microplasty instrumentation and following Microplasty surgical technique (Biomet Orthopedics). Intraoperative local infiltration analgesia is used for postoperative pain management. Drain is not used.

Also known as: Oxford phase 3, unicondylar knee artrhoplasty

Unicondylar Knee Replacement

Total Knee Replacement PROCEDURE

TKA is performed through a standard medial parapatellar incision, which provides easy access to the knee joint. Skin incision is done to midline. Intramedullary guide is used for alignment of femoral and tibia saw cuts and component positions. Components will be cemented in position. The patella will not be resurfaced. Intraoperative local infiltration analgesia (LIA) is used for postoperative pain management. Drain is not used.

Also known as: Triathlon CR

Total Knee Replacement

Eligibility Criteria

• Age: 45 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic medial knee OA with exposed bone on both femur and tibia.
• Age 45 to 79.
• Failed conservative treatment of knee OA.
• Mechanical axis 5 to 15 degrees varus.
• Functionally intact anterior cruciate ligament.
• Full thickness lateral cartilage present
• Correctable intra-articular varus deformity in knee 20 degrees flexion
• American Society of Anesthesiologists Physical Status Classification System (ASA) of 1, 2 or 3.

You may not qualify if:

• Rheumatoid arthritis or, other inflammatory disorders.
• Osteonecrosis
• Osteochondritis dissecans
• Symptomatic hip or spinal pathology
• Previous knee surgery other than diagnostic arthroscopy and medial menisectomy
• Previously had infectious arthritis
• Have significant damage to the patella-femoral joint especially on the lateral facet, patellar subluxation or concave patella.
• Previous ligament injury and instability
• Range of movement not within 15-100 degrees.
• Patient is planned to undergo simultaneous bilateral knee arthroplasty.

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (3)

Central Finland Central Hospital

Jyväskylä, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (22)

• Bedson J, Jordan K, Croft P. The prevalence and history of knee osteoarthritis in general practice: a case-control study. Fam Pract. 2005 Feb;22(1):103-8. doi: 10.1093/fampra/cmh700. Epub 2005 Jan 7.

  PMID: 15640302 BACKGROUND

• Fransen M, McConnell S. Land-based exercise for osteoarthritis of the knee: a metaanalysis of randomized controlled trials. J Rheumatol. 2009 Jun;36(6):1109-17. doi: 10.3899/jrheum.090058. Epub 2009 May 15.

  PMID: 19447940 BACKGROUND

• Zipple J, Meyer-Ralfs M. Themistocles Gluck (1853-1942), pioneer in endoprosthetics. Z Orthop Ihre Grenzgeb. 1975 Feb;113(1):134-9.

  PMID: 1098295 BACKGROUND

• Insall J, Walker P. Unicondylar knee replacement. Clin Orthop Relat Res. 1976 Oct;(120):83-5.

  PMID: 975670 BACKGROUND

• Lombardi AV Jr, Berend KR, Walter CA, Aziz-Jacobo J, Cheney NA. Is recovery faster for mobile-bearing unicompartmental than total knee arthroplasty? Clin Orthop Relat Res. 2009 Jun;467(6):1450-7. doi: 10.1007/s11999-009-0731-z. Epub 2009 Feb 19.

  PMID: 19225852 BACKGROUND

• Brown NM, Sheth NP, Davis K, Berend ME, Lombardi AV, Berend KR, Della Valle CJ. Total knee arthroplasty has higher postoperative morbidity than unicompartmental knee arthroplasty: a multicenter analysis. J Arthroplasty. 2012 Sep;27(8 Suppl):86-90. doi: 10.1016/j.arth.2012.03.022. Epub 2012 May 4.

  PMID: 22560653 BACKGROUND

• Niinimaki T, Eskelinen A, Makela K, Ohtonen P, Puhto AP, Remes V. Unicompartmental knee arthroplasty survivorship is lower than TKA survivorship: a 27-year Finnish registry study. Clin Orthop Relat Res. 2014 May;472(5):1496-501. doi: 10.1007/s11999-013-3347-2. Epub 2013 Nov 19.

  PMID: 24249531 BACKGROUND

• NJR. National Joint Registry for EnglandWales and Northern Ireland 10th annual report, 2013. 2013;10.

  BACKGROUND

• SKAR. The Swedish Knee Arthroplasty Register Annual Report. 2012. 2012.

  BACKGROUND

• AOANJRR. Australian Orthopaedic Association National Joint Replacement Registry Annual Report. 2011. 2011.

  BACKGROUND

• Sun PF, Jia YH. Mobile bearing UKA compared to fixed bearing TKA: a randomized prospective study. Knee. 2012 Mar;19(2):103-6. doi: 10.1016/j.knee.2011.01.006. Epub 2011 Feb 22.

  PMID: 21345681 BACKGROUND

• Newman JH, Ackroyd CE, Shah NA. Unicompartmental or total knee replacement? Five-year results of a prospective, randomised trial of 102 osteoarthritic knees with unicompartmental arthritis. J Bone Joint Surg Br. 1998 Sep;80(5):862-5. doi: 10.1302/0301-620x.80b5.8835.

  PMID: 9768899 BACKGROUND

• NAR. The Norwegian Arthroplasty Register. 2013.

  BACKGROUND

• NZJR. The New Zealand Joint Registry. Fifteen year report January 1999 to December 2013. 2014.

  BACKGROUND

• Pandit H, Liddle AD, Kendrick BJ, Jenkins C, Price AJ, Gill HS, Dodd CA, Murray DW. Improved fixation in cementless unicompartmental knee replacement: five-year results of a randomized controlled trial. J Bone Joint Surg Am. 2013 Aug 7;95(15):1365-72. doi: 10.2106/JBJS.L.01005.

  PMID: 23925740 BACKGROUND

• Liddle AD, Pandit H, O'Brien S, Doran E, Penny ID, Hooper GJ, Burn PJ, Dodd CA, Beverland DE, Maxwell AR, Murray DW. Cementless fixation in Oxford unicompartmental knee replacement: a multicentre study of 1000 knees. Bone Joint J. 2013 Feb;95-B(2):181-7. doi: 10.1302/0301-620X.95B2.30411.

  PMID: 23365026 BACKGROUND

• Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.

  PMID: 12801417 BACKGROUND

• Collins NJ, Roos EM. Patient-reported outcomes for total hip and knee arthroplasty: commonly used instruments and attributes of a "good" measure. Clin Geriatr Med. 2012 Aug;28(3):367-94. doi: 10.1016/j.cger.2012.05.007. Epub 2012 Jun 22.

  PMID: 22840304 BACKGROUND

• Beard DJ, Harris K, Dawson J, Doll H, Murray DW, Carr AJ, Price AJ. Meaningful changes for the Oxford hip and knee scores after joint replacement surgery. J Clin Epidemiol. 2015 Jan;68(1):73-9. doi: 10.1016/j.jclinepi.2014.08.009. Epub 2014 Oct 31.

  PMID: 25441700 BACKGROUND

• Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.

  PMID: 19025523 BACKGROUND

• Kerr DR, Kohan L. Local infiltration analgesia: a technique for the control of acute postoperative pain following knee and hip surgery: a case study of 325 patients. Acta Orthop. 2008 Apr;79(2):174-83. doi: 10.1080/17453670710014950.

  PMID: 18484242 BACKGROUND

• Knifsund J, Niinimaki T, Nurmi H, Toom A, Keemu H, Laaksonen I, Seppanen M, Liukas A, Pamilo K, Vahlberg T, Aarimaa V, Makela KT. Functional results of total-knee arthroplasty versus medial unicompartmental arthroplasty: two-year results of a randomised, assessor-blinded multicentre trial. BMJ Open. 2021 Jun 23;11(6):e046731. doi: 10.1136/bmjopen-2020-046731.

  PMID: 34162649 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Tuukka Niinimäki, MD PhD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

• Heikki Nurmi, MD

  Central Finland Central Hospital

  PRINCIPAL INVESTIGATOR

• Alar Toom, MD PhD

  Central Finland Central Hospital

  PRINCIPAL INVESTIGATOR

• Jani Knifsund, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

• Keijo Mäkelä, Adj. Prof.

  Turku University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 25, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2018
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

FI (3)