ArthritisNCT02905097
Post-marketing Surveillance Study of the Triathlon Tritanium Baseplate
An observational study of Arthritis, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial summary
The aim of the study is to assess the performance of the cementless Triathlon Tritanium tibial baseplate for total knee replacement, with a minimum follow up of 5 years. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arthritis
- What is being tested?
- Knee Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2018to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been referred to the Golden Jubilee National Hospital for total knee replacement.
Who may be able to join
- Unilateral TKA
- Age 18-75 years
- BMI <40
- From one of the following health boards: Ayrshire \& Arran, Forth Valley, Greater Glasgow \& Clyde, Highland, Lanarkshire or Lothian
- Suitable to receive the study implant
Who cannot join
- Revision of existing knee replacement
- Previous hip or knee replacement surgery if within the last 12 months
- Previous ankle surgery
- Diagnosed osteopenia or osteoporosis
- Proximal tibial bone defects
- Unable to give informed consent
- Unwilling to take part
- Unable to return to the Golden Jubilee National Hospital for followup appointments
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire, G81 4dy
About this study
Official title: Five Year Survival and Functional Assessment of the Triathlon Cementless Total Knee System Using the Tritanium Tibial Baseplate
The aim of the study is to assess the performance of the cementless Triathlon Tritanium tibial baseplate for total knee replacement, with a minimum follow up of 5 years.
Read the detailed description
All potential total knee arthroplasty patients from two consultant orthopaedic surgeons at the Golden Jubilee National Hospital (GJNH) will be screened in relation to the inclusion/exclusion criteria. Invitation letters and participant information sheets (PIS) will be sent out to suitable patients who have been referred to the GJNH for total knee replacement (allocated patients) prior to their pre-operative consultation with their surgeon. They will be approached at their consultation visit to seek consent to take part in the study. Patients who have been referred to the GJNH for assessment for a knee replacement (see and treat patients) will be approached only if they are deemed eligible for knee replacement by their consultant, and will be given a copy of the participant information sheet along with the invitation letter. They will be approached for consent to take part in the study at their pre-operative assessment. All patients will be given the opportunity to ask questions about the study before signing the consent form. Consent will be taken by the chief investigator or their delegate, using a signed form.
One hundred patients will be recruited to the study. They will have their surgery performed by one of the participating consultants using the study implant, the Triathlon Tritanium cementless tibial baseplate manufactured by Stryker Corporation.
Participants will receive their standard in-patient care and rehabilitation. Standard hospital care for knee arthroplasty patients is for them to return to the hospital for a post-operative review at 6 weeks and then 1 year and 7 years after operation. Study participants will also be asked to attend the GJNH for two additional research specific appointments at six months and five years. They will be also contacted by post or via telephone to complete a study questionnaire (patient satisfaction) at 3 years post operation.
During the standard care appointments, patients will be reviewed by a member of the arthroplasty team who will collect routine data on the clinical and functional outcomes and implant stability. These data include the Oxford Knee Score (OKS), EURO Quality of life questionnaire (EQ-5D 5L), patient satisfaction and standard radiographic assessment of the implant.
Detailed radiographic analysis will be carried out on radiographs collected as standard and specifically for the study. These will be post-operation at day one (standard), 6 weeks (standard), 6 months (study), 1 year (standard) and the 5 years (study) time points. Study specific radiographic assessment will consist of assessment for radiolucency and osteolysis at specific regions around the tibial and femoral components. Pre-operatively, a standard weight bearing long- leg anterior-posterior (AP) view, lateral view and a skyline view is obtained as per standard care. Post-operatively, standard care consists of a standard weight bearing long-leg AP radiograph at 6 weeks and a short AP and Lateral view at all other reviews.
Study participants will also have two sessions of specialised functional assessment (biomechanical movement analysis and 6-minute walk test) before operation and 1 year after operation during their standard pre and postoperative visits. Biomechanical movement analysis will be carried out in an on-site movement analysis laboratory. Study participants will be required to wear suitable clothing (e.g. tee shirt and shorts) and be barefoot. A number of reflective markers will be attached to specific locations on the body using suitable double sided tape which can be tracked by a number of infrared cameras. participants will be asked to perform the following tasks; walking, stepping up, stepping down, sit-to-stand, stand-to-sit and single leg balance. Each task will be performed at least three times to enable the collection of three good sets of data. In addition, the two stepping tasks will be repeated for each limb. The single leg balance will be performed once for each leg and data will be collected for 30 seconds per limb. A motion capture system will collect limb and torso movements during the task performances while force plates will collect ground reaction forces. The 6-minute walk test requires the participant to walk around a course during a six minute period. They are allowed to have rest breaks for as long and as often as they require. They will be asked to stop walking six minutes after the start of the test and the distance covered during the period will be noted.
- Conditions
- Arthritis
- Being tested
- Knee Replacement
- Keywords
- Knee arthroplasty, Total, Knee replacement, Total, Survival rate, Osseointegration, Gait
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee ReplacementProcedure or surgery
Also called Knee Arthroplasty
Surgical replacement of arthritic knee with an implant
| Study group | Role | What they receive |
|---|---|---|
| Arthroplasty cohort | A cohort of patients who will undergo knee replacement surgery and will receive Triathlon Tritanium (cementless) tibial implant. Receives: Procedure: Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival at five years
Kaplan-Meier implant survival at 5 years
Measured: 5 years
Secondary outcomes (18)
Component loosening rate
Number of loose components reported
Measured: 5 years
Fracture rate
Number of peri-prosthetic fractures reported
Measured: 5 years
Infection rate
Number of infections reported
Measured: 5 years
Radiolucency
Degree of radiolucent lines around the components
Measured: review at 6 weeks, 6 months, 1 and 5 years
Bone quality
Evidence of bony ingrowth or osteolysis
Measured: review at 6 weeks, 6 months, 1 and 5 years
Component migration
Component movement in mm or degrees from the one day post-operative position
Measured: review at 6 weeks, 6 months, 1 and 5 years
Oxford Knee Score
Patient-reported knee pain and function
Measured: 6 weeks, 6 months, 1, 3 and 5 years
EQ5D-5L
Patient-reported quality of life
Measured: 6 weeks, 6 months, 1, 3 and 5 years
Patient satisfaction
Patient-reported satisfaction of the knee using a five point Likert scale
Measured: 6 weeks, 6 months, 1, 3, and 5 years
Knee function during walking
Knee angles of movement and loads collected using clinical movement analysis
Measured: 1 year
Knee function during stepping up
Knee angles of movement and loads collected using clinical movement analysis
Measured: 1 year
Knee function during stepping down
Knee angles of movement and loads collected using clinical movement analysis
Measured: 1 year
Knee function during sit-to-stand
Knee angles of movement and loads collected using clinical movement analysis
Measured: 1 year
Knee function during stand-sit-to
Knee angles of movement and loads collected using clinical movement analysis
Measured: 1 year
Knee stability during single leg balance
Body sway collected using clinical movement analysis in mm
Measured: 1 year
6 minute walk test
Aerobic endurance assessed by the distance walked (m) in a six minutes
Measured: 1 year
Revision rate
Number of cases revised for any reason or for infection
Measured: 5 years
Surgeon feedback
Surgeon assessment of the implant ease of implantation using a questionnaire
Measured: 1 day post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start5 Jan 2018
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Collaborators
- Stryker GI Ltd.
- Responsible party
- Sponsor
- Investigators
- Nicholas Ohly, MBBS, FRCSEd, Principal investigator, nick.ohly@gjnh.scot.nhs.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905097
- Sponsor's protocol ID
- Ortho 16-04
- Status last verified
- Jul 2019
- First submitted
- 14 Sep 2016
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim YH, Park JW, Lim HM, Park ES. Cementless and cemented total knee arthroplasty in patients younger than fifty five years. Which is better? Int Orthop. 2014 Feb;38(2):297-303. doi: 10.1007/s00264-013-2243-4. Epub 2014 Jan 14.
PubMed 24420155Aprato A, Risitano S, Sabatini L, Giachino M, Agati G, Masse A. Cementless total knee arthroplasty. Ann Transl Med. 2016 Apr;4(7):129. doi: 10.21037/atm.2016.01.34.
PubMed 27162779Lombardi AV Jr, Berasi CC, Berend KR. Evolution of tibial fixation in total knee arthroplasty. J Arthroplasty. 2007 Jun;22(4 Suppl 1):25-9. doi: 10.1016/j.arth.2007.02.006.
PubMed 17570273Naudie DD, Ammeen DJ, Engh GA, Rorabeck CH. Wear and osteolysis around total knee arthroplasty. J Am Acad Orthop Surg. 2007 Jan;15(1):53-64. doi: 10.5435/00124635-200701000-00006.
PubMed 17213382Bassett RW. Results of 1,000 Performance knees: cementless versus cemented fixation. J Arthroplasty. 1998 Jun;13(4):409-13. doi: 10.1016/s0883-5403(98)90006-7.
PubMed 9645521Albrektsson BE, Carlsson LV, Freeman MA, Herberts P, Ryd L. Proximally cemented versus uncemented Freeman-Samuelson knee arthroplasty. A prospective randomised study. J Bone Joint Surg Br. 1992 Mar;74(2):233-8. doi: 10.1302/0301-620X.74B2.1544959.
PubMed 1544959Berry DJ, Wold LE, Rand JA. Extensive osteolysis around an aseptic, stable, uncemented total knee replacement. Clin Orthop Relat Res. 1993 Aug;(293):204-7.
PubMed 8339482De Martino I, D'Apolito R, Sculco PK, Poultsides LA, Gasparini G. Total Knee Arthroplasty Using Cementless Porous Tantalum Monoblock Tibial Component: A Minimum 10-Year Follow-Up. J Arthroplasty. 2016 Oct;31(10):2193-8. doi: 10.1016/j.arth.2016.03.057. Epub 2016 Apr 12.
PubMed 27172865Harwin SF, Kester MA, Malkani AL, Manley MT. Excellent fixation achieved with cementless posteriorly stabilized total knee arthroplasty. J Arthroplasty. 2013 Jan;28(1):7-13. doi: 10.1016/j.arth.2012.06.006. Epub 2012 Jul 31.
PubMed 22854342Melton JT, Mayahi R, Baxter SE, Facek M, Glezos C. Long-term outcome in an uncemented, hydroxyapatite-coated total knee replacement: a 15- to 18-year survivorship analysis. J Bone Joint Surg Br. 2012 Aug;94(8):1067-70. doi: 10.1302/0301-620X.94B8.28350.
PubMed 22844047Tai CC, Cross MJ. Five- to 12-year follow-up of a hydroxyapatite-coated, cementless total knee replacement in young, active patients. J Bone Joint Surg Br. 2006 Sep;88(9):1158-63. doi: 10.1302/0301-620X.88B9.17789.
PubMed 16943464Bagsby DT, Issa K, Smith LS, Elmallah RK, Mast LE, Harwin SF, Mont MA, Bhimani SJ, Malkani AL. Cemented vs Cementless Total Knee Arthroplasty in Morbidly Obese Patients. J Arthroplasty. 2016 Aug;31(8):1727-31. doi: 10.1016/j.arth.2016.01.025. Epub 2016 Jan 29.
PubMed 26895823Mont MA, Pivec R, Issa K, Kapadia BH, Maheshwari A, Harwin SF. Long-term implant survivorship of cementless total knee arthroplasty: a systematic review of the literature and meta-analysis. J Knee Surg. 2014 Oct;27(5):369-76. doi: 10.1055/s-0033-1361952. Epub 2013 Dec 7.
PubMed 24318196Fricka KB, Sritulanondha S, McAsey CJ. To Cement or Not? Two-Year Results of a Prospective, Randomized Study Comparing Cemented Vs. Cementless Total Knee Arthroplasty (TKA). J Arthroplasty. 2015 Sep;30(9 Suppl):55-8. doi: 10.1016/j.arth.2015.04.049. Epub 2015 Jun 3.
PubMed 26118567Khaw FM, Kirk LM, Morris RW, Gregg PJ. A randomised, controlled trial of cemented versus cementless press-fit condylar total knee replacement. Ten-year survival analysis. J Bone Joint Surg Br. 2002 Jul;84(5):658-66. doi: 10.1302/0301-620x.84b5.12692.
PubMed 12188480
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Year Survival and Functional Assessment of the Triathlon Cementless Total Knee System Using the Tritanium Tibial Baseplate
- ClinicalTrials.gov ID
- NCT02905097
- Acronym / sponsor ID
- Ortho 16-04
- Conditions
- Arthritis
- Keywords
- Knee arthroplasty, Total, Knee replacement, Total, Survival rate, Osseointegration, Gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Collaborators
- Stryker GI Ltd.
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess the performance of the cementless Triathlon Tritanium tibial baseplate for total knee replacement, with a minimum follow up of 5 years.
Detailed description
All potential total knee arthroplasty patients from two consultant orthopaedic surgeons at the Golden Jubilee National Hospital (GJNH) will be screened in relation to the inclusion/exclusion criteria. Invitation letters and participant information sheets (PIS) will be sent out to suitable patients who have been referred to the GJNH for total knee replacement (allocated patients) prior to their pre-operative consultation with their surgeon. They will be approached at their consultation visit to seek consent to take part in the study. Patients who have been referred to the GJNH for assessment for a knee replacement (see and treat patients) will be approached only if they are deemed eligible for knee replacement by their consultant, and will be given a copy of the participant information sheet along with the invitation letter. They will be approached for consent to take part in the study at their pre-operative assessment. All patients will be given the opportunity to ask questions about the study before signing the consent form. Consent will be taken by the chief investigator or their delegate, using a signed form.
One hundred patients will be recruited to the study. They will have their surgery performed by one of the participating consultants using the study implant, the Triathlon Tritanium cementless tibial baseplate manufactured by Stryker Corporation.
Participants will receive their standard in-patient care and rehabilitation. Standard hospital care for knee arthroplasty patients is for them to return to the hospital for a post-operative review at 6 weeks and then 1 year and 7 years after operation. Study participants will also be asked to attend the GJNH for two additional research specific appointments at six months and five years. They will be also contacted by post or via telephone to complete a study questionnaire (patient satisfaction) at 3 years post operation.
During the standard care appointments, patients will be reviewed by a member of the arthroplasty team who will collect routine data on the clinical and functional outcomes and implant stability. These data include the Oxford Knee Score (OKS), EURO Quality of life questionnaire (EQ-5D 5L), patient satisfaction and standard radiographic assessment of the implant.
Detailed radiographic analysis will be carried out on radiographs collected as standard and specifically for the study. These will be post-operation at day one (standard), 6 weeks (standard), 6 months (study), 1 year (standard) and the 5 years (study) time points. Study specific radiographic assessment will consist of assessment for radiolucency and osteolysis at specific regions around the tibial and femoral components. Pre-operatively, a standard weight bearing long- leg anterior-posterior (AP) view, lateral view and a skyline view is obtained as per standard care. Post-operatively, standard care consists of a standard weight bearing long-leg AP radiograph at 6 weeks and a short AP and Lateral view at all other reviews.
Study participants will also have two sessions of specialised functional assessment (biomechanical movement analysis and 6-minute walk test) before operation and 1 year after operation during their standard pre and postoperative visits. Biomechanical movement analysis will be carried out in an on-site movement analysis laboratory. Study participants will be required to wear suitable clothing (e.g. tee shirt and shorts) and be barefoot. A number of reflective markers will be attached to specific locations on the body using suitable double sided tape which can be tracked by a number of infrared cameras. participants will be asked to perform the following tasks; walking, stepping up, stepping down, sit-to-stand, stand-to-sit and single leg balance. Each task will be performed at least three times to enable the collection of three good sets of data. In addition, the two stepping tasks will be repeated for each limb. The single leg balance will be performed once for each leg and data will be collected for 30 seconds per limb. A motion capture system will collect limb and torso movements during the task performances while force plates will collect ground reaction forces. The 6-minute walk test requires the participant to walk around a course during a six minute period. They are allowed to have rest breaks for as long and as often as they require. They will be asked to stop walking six minutes after the start of the test and the distance covered during the period will be noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroplasty cohort | – | Procedure: Knee ReplacementA cohort of patients who will undergo knee replacement surgery and will receive Triathlon Tritanium (cementless) tibial implant. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been referred to the Golden Jubilee National Hospital for total knee replacement.
Key inclusion criteria (5 listed)
- Unilateral TKA
- Age 18-75 years
- BMI <40
- From one of the following health boards: Ayrshire \& Arran, Forth Valley, Greater Glasgow \& Clyde, Highland, Lanarkshire or Lothian
- Suitable to receive the study implant
Key exclusion criteria (8 listed)
- Revision of existing knee replacement
- Previous hip or knee replacement surgery if within the last 12 months
- Previous ankle surgery
- Diagnosed osteopenia or osteoporosis
- Proximal tibial bone defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee ReplacementAlso: Knee ArthroplastySurgical replacement of arthritic knee with an implant | Procedure or surgery | Arthroplasty cohort |
Primary outcome
Implant survival at five years
Time frame: 5 years
Kaplan-Meier implant survival at 5 years
18 secondary outcomes
Component loosening rate
Time frame: 5 years
Fracture rate
Time frame: 5 years
Infection rate
Time frame: 5 years
Radiolucency
Time frame: review at 6 weeks, 6 months, 1 and 5 years
Bone quality
Time frame: review at 6 weeks, 6 months, 1 and 5 years
Component migration
Time frame: review at 6 weeks, 6 months, 1 and 5 years
Oxford Knee Score
Time frame: 6 weeks, 6 months, 1, 3 and 5 years
EQ5D-5L
Time frame: 6 weeks, 6 months, 1, 3 and 5 years
Patient satisfaction
Time frame: 6 weeks, 6 months, 1, 3, and 5 years
Knee function during walking
Time frame: 1 year
Knee function during stepping up
Time frame: 1 year
Knee function during stepping down
Time frame: 1 year
Knee function during sit-to-stand
Time frame: 1 year
Knee function during stand-sit-to
Time frame: 1 year
Knee stability during single leg balance
Time frame: 1 year
6 minute walk test
Time frame: 1 year
Revision rate
Time frame: 5 years
Surgeon feedback
Time frame: 1 day post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Background: PubMed 24420155Kim YH, Park JW, Lim HM, Park ES. Cementless and cemented total knee arthroplasty in patients younger than fifty five years. Which is better? Int Orthop. 2014 Feb;38(2):297-303. doi: 10.1007/s00264-013-2243-4. Epub 2014 Jan 14.
- Background: PubMed 27162779Aprato A, Risitano S, Sabatini L, Giachino M, Agati G, Masse A. Cementless total knee arthroplasty. Ann Transl Med. 2016 Apr;4(7):129. doi: 10.21037/atm.2016.01.34.
- Background: PubMed 17570273Lombardi AV Jr, Berasi CC, Berend KR. Evolution of tibial fixation in total knee arthroplasty. J Arthroplasty. 2007 Jun;22(4 Suppl 1):25-9. doi: 10.1016/j.arth.2007.02.006.
- Background: PubMed 17213382Naudie DD, Ammeen DJ, Engh GA, Rorabeck CH. Wear and osteolysis around total knee arthroplasty. J Am Acad Orthop Surg. 2007 Jan;15(1):53-64. doi: 10.5435/00124635-200701000-00006.
- Background: PubMed 9645521Bassett RW. Results of 1,000 Performance knees: cementless versus cemented fixation. J Arthroplasty. 1998 Jun;13(4):409-13. doi: 10.1016/s0883-5403(98)90006-7.
- Background: PubMed 1544959Albrektsson BE, Carlsson LV, Freeman MA, Herberts P, Ryd L. Proximally cemented versus uncemented Freeman-Samuelson knee arthroplasty. A prospective randomised study. J Bone Joint Surg Br. 1992 Mar;74(2):233-8. doi: 10.1302/0301-620X.74B2.1544959.
- Background: PubMed 8339482Berry DJ, Wold LE, Rand JA. Extensive osteolysis around an aseptic, stable, uncemented total knee replacement. Clin Orthop Relat Res. 1993 Aug;(293):204-7.
- Background: PubMed 27172865De Martino I, D'Apolito R, Sculco PK, Poultsides LA, Gasparini G. Total Knee Arthroplasty Using Cementless Porous Tantalum Monoblock Tibial Component: A Minimum 10-Year Follow-Up. J Arthroplasty. 2016 Oct;31(10):2193-8. doi: 10.1016/j.arth.2016.03.057. Epub 2016 Apr 12.
- Background: PubMed 22854342Harwin SF, Kester MA, Malkani AL, Manley MT. Excellent fixation achieved with cementless posteriorly stabilized total knee arthroplasty. J Arthroplasty. 2013 Jan;28(1):7-13. doi: 10.1016/j.arth.2012.06.006. Epub 2012 Jul 31.
- Background: PubMed 22844047Melton JT, Mayahi R, Baxter SE, Facek M, Glezos C. Long-term outcome in an uncemented, hydroxyapatite-coated total knee replacement: a 15- to 18-year survivorship analysis. J Bone Joint Surg Br. 2012 Aug;94(8):1067-70. doi: 10.1302/0301-620X.94B8.28350.
- Background: PubMed 16943464Tai CC, Cross MJ. Five- to 12-year follow-up of a hydroxyapatite-coated, cementless total knee replacement in young, active patients. J Bone Joint Surg Br. 2006 Sep;88(9):1158-63. doi: 10.1302/0301-620X.88B9.17789.
- Background: PubMed 26895823Bagsby DT, Issa K, Smith LS, Elmallah RK, Mast LE, Harwin SF, Mont MA, Bhimani SJ, Malkani AL. Cemented vs Cementless Total Knee Arthroplasty in Morbidly Obese Patients. J Arthroplasty. 2016 Aug;31(8):1727-31. doi: 10.1016/j.arth.2016.01.025. Epub 2016 Jan 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Ohly, MBBS, FRCSEd principal investigator
nick.ohly@gjnh.scot.nhs.uk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival at five years (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02905097, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.