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02 September 2010
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| [ Print-friendly version ] |
| Comparison of haptic assisted versus non-assisted uni-compartmental knee arthroplasty |
| ISRCTN | ISRCTN77119437 |
| ClinicalTrials.gov identifier | |
| Public title | Comparison of haptic assisted versus non-assisted uni-compartmental knee arthroplasty |
| Scientific title | Comparison of post-operative function following MAKOplasty® unicondylar knee arthroplasty, using MAKOplasty® and the MAKO RIO® System, versus OXFORD® partial knee arthroplasty |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | MAKOplasty® performed with assistive haptic arm technology will result in less variability in post-operative mechanical knee alignment, and an associated improvement in post-operative function, activity and satisfaction, as compared to the standard unicompartmental knee arthroplasty. |
| Ethics approval |
Pending as of 26/01/2010:
1. NHS Research Ethics Committee, Glasgow Royal Infirmary 2. Ethics Committee, Research and Innovation, University of Strathclyde |
| Study design | Prospective single-blind single centre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Early-mid stage osteoarthritis of the knee |
| Participants - inclusion criteria |
1. Male or female subjects may be recruited to the evaluation
2. Age - there are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a unicondylar knee arthroplasty using either of the two systems available in the evaluation. 3. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained 4. 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 5. Subjects who require a unicondylar knee arthroplasty for primary surgical management of idiopathic osteoarthritis 6. Patients who in the opinion of the Chief Investigator are considered to be suitable for treatment with a MAKOplasty® and OXFORD® unicondylar knee replacement |
| Participants - exclusion criteria |
1. Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in the study
2. Patients who require revision knee arthroplasty surgery 3. Patients with any tibial deformity requiring tibial component augmentation 4. Patients whom, in the opinion of the Chief Investigator, require a total knee prosthesis 5. Patients with inflammatory polyarthritis 6. Disorders of the feet, ankles, hips or spine causing significant abnormal gait or significant pain 7. Neurological conditions affecting movement 8. Patients with a pathology which, in the opinion of the Chief Investigator, will adversely affect healing 9. Patients with other disorders which, in the opinion of the Chief Investigator, will/could impair rehabilitation 10. Contra-indications for use of the device, as detailed in the package insert 11. Women who are pregnant. If there is uncertainty over pregnancy then a pregnancy test will be conducted. 12. Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes 13. Subjects who are currently involved in another clinical study with an investigational product 14. Subjects who are currently involved in any injury litigation claims |
| Anticipated start date | 19/04/2010 |
| Anticipated end date | 18/10/2021 |
| Status of trial | Ongoing |
| Patient information material | Not yet available in web format, please contact iain.anthony@ggc.scot.nhs.uk to request a patient information sheet. |
| Target number of participants | 150 (75 within each treatment group) |
| Interventions |
1. Treatment group: MAKOplasty® unicondylar knee arthroplasty, using the RESTORIS implant and the MAKO RIO® Robotic Arm Interactive Orthopaedic System
2. Control group: OXFORD® Partial Knee Arthroplasty Total duration of treatment will be 1 - 2 hours. Total duration of follow-up will be 10 years. |
| Primary outcome measure(s) | Mechanical knee alignment (tibiofemoral angle, degrees) - measured from long-leg scans at 3 months post-operatively |
| Secondary outcome measure(s) |
1. Oxford Knee Scores (OKS) - measured pre-operatively and 3 months, 1, 3, 5 and 10 years post-operatively
2. American Knee Society Score (AKSS) - measured pre-operatively and 3 months, 1, 3, 5 and 10 years post-operatively 3. Pain Visual Analogue Score (VAS) - measured daily for 1 week post-operatively, weekly for 8 weeks post-operatively and at 3 months, 1, 3, 5 and 10 years post-operatively 4. Fuctional section of AKSS - measured daily for 1 week post-operatively, weekly for 8 weeks post-operatively and at 3 months, 1, 3, 5 and 10 years post-operatively 5. 12-item short form health survey (SF-12) - measured pre-operatively and 1 year post-operatively 6. Canadian Occupational Performance Score (COPM) - measured pre-operatively and 1 year post-operatively 7. UCLA activity scale - measured pre-operatively and 1 year post-operatively 8. Hospital Anxiety and Depression (HAD) score - measured pre-operatively and 1 year post-operatively 9. Operation times - measured peri-operatively 10. Complications - measured any time following surgery 11. Knee angles during functional tasks - measured 1 year post-operatively 12. Frequency/type of activity - measured over 1 day at 1 year post-operatively 13. Gait velocity, knee angles and moments - measured 1 year post-operatively |
| Sources of funding | MAKO Surgical Corp. (USA) |
| Trial website | |
| Publications | |
| Contact name | Mr Mark Blyth |
| Address |
Glasgow Royal Infirmary
Department of Trauma and Orthopaedics 84 Castle Street |
| City/town | Glasgow |
| Zip/Postcode | G4 0SF |
| Country | United Kingdom |
| Sponsor | NHS Greater Glasgow and Clyde (UK) |
| Address |
4th Floor Walton Building
Glasgow Royal Infirmary 84 Castle Street |
| City/town | Glasgow |
| Zip/Postcode | G4 0SF |
| Country | United Kingdom |
| Sponsor website: | http://www.nhsggc.org.uk/content/ |
| Date applied | 26/01/2010 |
| Last edited | 05/02/2010 |
| Date ISRCTN assigned | 05/02/2010 |
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| © 2010 ISRCTN unless otherwise stated. | |
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