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Study protocol
CAPAbility: Comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial.
Celia Clarke
University of East Anglia
Corresponding Author
ORCiD: https://orcid.org/0000-0001-6584-9601
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Osteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate regarding the safety and efficacy of modern TKR, up to 20% of patients report poor functional outcomes following surgery. This study will investigate the functional outcome of two TKR; the JOURNEY II Bi Cruciate Stabilised knee, a newer prosthesis designed to provide guided motion and improve knee kinematics by more closely approximating a normal knee and the GENESIS II, a proven existing design. Aim: To compare the change in patient reported outcome scores of the JOURNEY II BCS and the GENESIS II from pre-operation to six months post-operation.
Methods : CAPAbility is a pragmatic, blinded, two-arm parallel, randomised controlled trial recruiting patients with primary osteoarthritis due to have unilateral TKR surgery across two UK hospitals. Eligible participants (n=80) will be randomly allocated to receive either the JOURNEY II or the GENESIS II BCS knee prosthesis. Baseline measures will be taken prior to surgery. Patients will be followed at one week, six to eight weeks and six months post-operatively. Primary outcome is the Oxford Knee Score (OKS) at six months post-operatively. Secondary outcomes include: other patient-reported outcome measures (PROMs), biomechanical, radiological (computerised tomography, (CT)), clinical efficacy and safety outcomes. An embedded qualitative study will also investigate patients’ perspectives via interview pre- and post-surgery on variables known to affect the outcome of TKR surgery. A sub-sample (n=30) will have additional in-depth interviews to explore themes identified. The surgeons’ perspectives on the operation will be investigated by a group interview after all participants have undergone surgery.
Discussion : This trial will evaluate two generations of TKR using PROMS, kinematic and radiological analyses and qualitative outcomes from the patient perspective.
Keywords
Total Knee Arthroplasty; knee replacement; functional ability; knee prosthesis; kinematics; primary 0steoarthritis.
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Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 19 Dec, 2019
Published
On 24 Feb, 2020
No community comments so far
Editorial decision: Accept
On 05 Feb, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Review #1 received
Received 06 Jan, 2020
Editor assigned
On 17 Dec, 2019
Submission checks complete
On 16 Dec, 2019
No comments provided
Editorial decision: Major revision
On 17 Nov, 2019
Review #2 received
Received 05 Nov, 2019
Review #1 received
Received 24 Oct, 2019
Reviewer #2 agreed
On 21 Oct, 2019
Reviewers invited
Invitations sent on 19 Oct, 2019
Reviewer #1 agreed
On 19 Oct, 2019
Editor assigned
On 24 Sep, 2019
First submitted
On 12 Aug, 2019
Submission checks complete
On 12 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
CAPAbility: Comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial.
Celia Clarke
University of East Anglia
Corresponding Author
ORCiD: https://orcid.org/0000-0001-6584-9601
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 19 Dec, 2019
Published
On 24 Feb, 2020
No community comments so far
Editorial decision: Accept
On 05 Feb, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Review #1 received
Received 06 Jan, 2020
Editor assigned
On 17 Dec, 2019
Submission checks complete
On 16 Dec, 2019
No comments provided
Editorial decision: Major revision
On 17 Nov, 2019
Review #2 received
Received 05 Nov, 2019
Review #1 received
Received 24 Oct, 2019
Reviewer #2 agreed
On 21 Oct, 2019
Reviewers invited
Invitations sent on 19 Oct, 2019
Reviewer #1 agreed
On 19 Oct, 2019
Editor assigned
On 24 Sep, 2019
First submitted
On 12 Aug, 2019
Submission checks complete
On 12 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Osteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate regarding the safety and efficacy of modern TKR, up to 20% of patients report poor functional outcomes following surgery. This study will investigate the functional outcome of two TKR; the JOURNEY II Bi Cruciate Stabilised knee, a newer prosthesis designed to provide guided motion and improve knee kinematics by more closely approximating a normal knee and the GENESIS II, a proven existing design. Aim: To compare the change in patient reported outcome scores of the JOURNEY II BCS and the GENESIS II from pre-operation to six months post-operation.
Methods : CAPAbility is a pragmatic, blinded, two-arm parallel, randomised controlled trial recruiting patients with primary osteoarthritis due to have unilateral TKR surgery across two UK hospitals. Eligible participants (n=80) will be randomly allocated to receive either the JOURNEY II or the GENESIS II BCS knee prosthesis. Baseline measures will be taken prior to surgery. Patients will be followed at one week, six to eight weeks and six months post-operatively. Primary outcome is the Oxford Knee Score (OKS) at six months post-operatively. Secondary outcomes include: other patient-reported outcome measures (PROMs), biomechanical, radiological (computerised tomography, (CT)), clinical efficacy and safety outcomes. An embedded qualitative study will also investigate patients’ perspectives via interview pre- and post-surgery on variables known to affect the outcome of TKR surgery. A sub-sample (n=30) will have additional in-depth interviews to explore themes identified. The surgeons’ perspectives on the operation will be investigated by a group interview after all participants have undergone surgery.
Discussion : This trial will evaluate two generations of TKR using PROMS, kinematic and radiological analyses and qualitative outcomes from the patient perspective.
Figure 1