OsteoarthritisNCT02268097
Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty
A study testing Patellar resurfacing with freehand technique and Patellar resurfacing with resection guide technique in people with Osteoarthritis, run by Peking University Third Hospital at 1 site in China.
Trial summary
The aim of this prospective, randomized study was to compare the clinical and radiological results of "free-hand" technique and "resection guide" technique for preparing patella during total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Patellar resurfacing with freehand technique and Patellar resurfacing with resection guide technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2014to 15 Jul 2017
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of primary osteoarthritis of the knee, with Ahlbäck grade of ≥2 (symptoms persisting after conservative treatment for at least 3 months) knees with <20° varus or <15° valgus deformity patellar thickness is more than 21mm
Who cannot join
- restricted motion (flexion contracture of >25°) patella alta (Insall-Salvati ratio of <0.6) history of previous knee surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Sports Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty.A Prospective, Randomized, Double-blind Study
The aim of this prospective, randomized study was to compare the clinical and radiological results of "free-hand" technique and "resection guide" technique for preparing patella during total knee arthroplasty.
Read the detailed description
With improved surgical techniques and implant designs, patella resurfacing has been favored by increasing surgeons. When performing the resection, several principles such as restoring the original patellar thickness, avoiding over or under resection must be complied in order to achieve satisfactory outcomes.This study was conducted to compared the outcomes of two commonly adopted methods for performing patellar resection in total knee arthroplasty. One hundred patients with osteoarthritis were recruited in the clinical trial using Nexgen Legacy Posterior Stabilized-Flex prosthesis. Patients were randomized to receive "free-hand" technique and "resection guide" technique when performing patellar resection in total knee arthroplasty. Patients were evaluated preoperatively and at follow-up visits conducted at twelve months, at twenty-four months. Clinical outcome was assessed and compared with use of the visual analogue pain scale (VAS), range of motion, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 (SF-36). Patellar alignment was assessed before surgery and at each follow-up by measuring the patellar tilt (PT) and lateral patellar displacement (PD). Prosthetic position and leg alignment were also compared between the two groups.
- Conditions
- Osteoarthritis
- Being tested
- Patellar resurfacing with freehand technique, Patellar resurfacing with resection guide technique
- Keywords
- patella, total knee arthroplasty, resection
- Medical subject headings
- Osteoarthritis, Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patellar resurfacing with freehand techniqueProcedure or surgery
Preparing patellar resurfacing during total knee arthroplasty with freehand
Patellar resurfacing with resection guide techniqueProcedure or surgery
Preparing patellar resurfacing during total knee arthroplasty with a resection guide
| Study group | Role | What they receive |
|---|---|---|
| Freehand | Experimental | Patellar resurfacing with freehand technique:Using freehand technique for patella preparation during total knee arthroplasty. Receives: Procedure: Patellar resurfacing with freehand technique |
| Resection guide | Active comparator | Patellar resurfacing with resection guide technique: Using patellar resection guide technique for patella preparation during total knee arthroplasty. Receives: Procedure: Patellar resurfacing with resection guide technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patellar tilt (PT)
The patellar tilt is the angle between the transverse axis of the patella and The patellar tilt is the angle between the transverse axis of the patella and the anterior intercondylar line.The PT was assessed by a blinded observer using 30° skyline radiographs.
Measured: 1 year
Secondary outcomes (8)
Knee Society Score (KSS)
The Knee Society's Knee Scoring System (KSS) has served as a simple, objective way to measure a patient's functional ability before and after total knee arthroplasty (TKA).Scale Name:score scale range:0~100,and a higher values represent a better outcome.
Measured: 1 year
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index is a tested questionnaire to assess symptoms and physical functional disability in patients with OA of the knee.Scale Name:score scale range:0~100,and a lesser values represent a better outcome.
Measured: 1 year
visual analogue pain scale (VAS)
Pain rating scales.Scale Name:score scale range:0~100,and a higher values represent a worse outcome
Measured: 1 year
Short Form-36 (SF-36)
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. A higher values represent a better outcome.
Measured: 1 year
leg alignment
Radiographic evaluation:The measurements were made by a blinded observer, in accordance with the principles stipulated by the Knee Society, by using computer-generated data derived from the digital radiographs.
Measured: 1 year
prosthetic position
Radiographic evaluation:The following parameters were measured: the coronal femoral component angle (α; angle between femoral shaft and transcondylar line of the femoral component); coronal tibial component angle (β; angle between the mechanical axis of the tibia and tibial base plate); sagittal femoral component angle (γ; angle of femoral component flexion); and sagittal tibial component angle (δ; posterior slope angle of the tibial component).
Measured: 1 year
Rang of motion
Functional evaluation:it is measured by a blinded observer using goniometer.
Measured: 1 year
patellar displacement (PD)
The patellar displacement is the lateral displacement of the median ridge of the patella from the intercondylar sulcus of the femur.The PD was assessed by a blinded observer using 30° skyline radiographs.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study start29 Oct 2014
- Primary completion15 Jul 2017 (estimated)
- Study completion15 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-kuo yu, Peking University Third Hospital
- Investigators
- Jia-Kuo Yu, Doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268097
- Sponsor's protocol ID
- YJK-003
- Status last verified
- Oct 2014
- First submitted
- 11 Oct 2014
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abdel MP, Parratte S, Budhiparama NC. The patella in total knee arthroplasty: to resurface or not is the question. Curr Rev Musculoskelet Med. 2014 Jun;7(2):117-24. doi: 10.1007/s12178-014-9212-4.
PubMed 24706154Breeman S, Campbell M, Dakin H, Fiddian N, Fitzpatrick R, Grant A, Gray A, Johnston L, Maclennan G, Morris R, Murray D; KAT Trial Group. Patellar resurfacing in total knee replacement: five-year clinical and economic results of a large randomized controlled trial. J Bone Joint Surg Am. 2011 Aug 17;93(16):1473-81. doi: 10.2106/JBJS.J.00725.
PubMed 22204002Camp CL, Bryan AJ, Walker JA, Trousdale RT. Surgical technique for symmetric patellar resurfacing during total knee arthroplasty. J Knee Surg. 2013 Aug;26(4):281-4. doi: 10.1055/s-0032-1330056. Epub 2013 Jan 8.
PubMed 23299953Bartlett DH, Franzen J. Accurate preparation of the patella during total knee arthroplasty. J Arthroplasty. 1993 Feb;8(1):75-82. doi: 10.1016/s0883-5403(06)80111-7.
PubMed 8436994Yuan F, Sun Z, Wang H, Chen Y, Yu J. Clinical and radiologic outcomes of two patellar resection techniques during total knee arthroplasty: a prospective randomized controlled study. Int Orthop. 2019 Oct;43(10):2293-2301. doi: 10.1007/s00264-018-4264-5. Epub 2018 Dec 11.
PubMed 30539221
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty.A Prospective, Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT02268097
- Acronym / sponsor ID
- YJK-003
- Conditions
- Osteoarthritis
- Keywords
- patella, total knee arthroplasty, resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 29 Oct 2014 (actual)
- Primary completion
- 15 Jul 2017 (estimated)
- Study completion
- 15 Jul 2017 (estimated)
- First posted
- 20 Oct 2014 (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 this prospective, randomized study was to compare the clinical and radiological results of "free-hand" technique and "resection guide" technique for preparing patella during total knee arthroplasty.
Detailed description
With improved surgical techniques and implant designs, patella resurfacing has been favored by increasing surgeons. When performing the resection, several principles such as restoring the original patellar thickness, avoiding over or under resection must be complied in order to achieve satisfactory outcomes.This study was conducted to compared the outcomes of two commonly adopted methods for performing patellar resection in total knee arthroplasty. One hundred patients with osteoarthritis were recruited in the clinical trial using Nexgen Legacy Posterior Stabilized-Flex prosthesis. Patients were randomized to receive "free-hand" technique and "resection guide" technique when performing patellar resection in total knee arthroplasty. Patients were evaluated preoperatively and at follow-up visits conducted at twelve months, at twenty-four months. Clinical outcome was assessed and compared with use of the visual analogue pain scale (VAS), range of motion, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 (SF-36). Patellar alignment was assessed before surgery and at each follow-up by measuring the patellar tilt (PT) and lateral patellar displacement (PD). Prosthetic position and leg alignment were also compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freehand | Experimental | Procedure: Patellar resurfacing with freehand techniquePatellar resurfacing with freehand technique:Using freehand technique for patella preparation during total knee arthroplasty. |
| Resection guide | Active comparator | Procedure: Patellar resurfacing with resection guide techniquePatellar resurfacing with resection guide technique: Using patellar resection guide technique for patella preparation during total knee arthroplasty. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of primary osteoarthritis of the knee, with Ahlbäck grade of ≥2 (symptoms persisting after conservative treatment for at least 3 months) knees with <20° varus or <15° valgus deformity patellar thickness is more than 21mm
Key exclusion criteria (1 listed)
- restricted motion (flexion contracture of >25°) patella alta (Insall-Salvati ratio of <0.6) history of previous knee surgery
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 |
|---|---|---|
| Patellar resurfacing with freehand techniquePreparing patellar resurfacing during total knee arthroplasty with freehand | Procedure or surgery | Freehand |
| Patellar resurfacing with resection guide techniquePreparing patellar resurfacing during total knee arthroplasty with a resection guide | Procedure or surgery | Resection guide |
Primary outcome
Patellar tilt (PT)
Time frame: 1 year
The patellar tilt is the angle between the transverse axis of the patella and The patellar tilt is the angle between the transverse axis of the patella and the anterior intercondylar line.The PT was assessed by a blinded observer using 30° skyline radiographs.
8 secondary outcomes
Knee Society Score (KSS)
Time frame: 1 year
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 1 year
visual analogue pain scale (VAS)
Time frame: 1 year
Short Form-36 (SF-36)
Time frame: 1 year
leg alignment
Time frame: 1 year
prosthetic position
Time frame: 1 year
Rang of motion
Time frame: 1 year
patellar displacement (PD)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Background: PubMed 24706154Abdel MP, Parratte S, Budhiparama NC. The patella in total knee arthroplasty: to resurface or not is the question. Curr Rev Musculoskelet Med. 2014 Jun;7(2):117-24. doi: 10.1007/s12178-014-9212-4.
- Background: PubMed 22204002Breeman S, Campbell M, Dakin H, Fiddian N, Fitzpatrick R, Grant A, Gray A, Johnston L, Maclennan G, Morris R, Murray D; KAT Trial Group. Patellar resurfacing in total knee replacement: five-year clinical and economic results of a large randomized controlled trial. J Bone Joint Surg Am. 2011 Aug 17;93(16):1473-81. doi: 10.2106/JBJS.J.00725.
- Background: PubMed 23299953Camp CL, Bryan AJ, Walker JA, Trousdale RT. Surgical technique for symmetric patellar resurfacing during total knee arthroplasty. J Knee Surg. 2013 Aug;26(4):281-4. doi: 10.1055/s-0032-1330056. Epub 2013 Jan 8.
- Background: PubMed 8436994Bartlett DH, Franzen J. Accurate preparation of the patella during total knee arthroplasty. J Arthroplasty. 1993 Feb;8(1):75-82. doi: 10.1016/s0883-5403(06)80111-7.
- Derived from this study: PubMed 30539221Yuan F, Sun Z, Wang H, Chen Y, Yu J. Clinical and radiologic outcomes of two patellar resection techniques during total knee arthroplasty: a prospective randomized controlled study. Int Orthop. 2019 Oct;43(10):2293-2301. doi: 10.1007/s00264-018-4264-5. Epub 2018 Dec 11.
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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.
Jia-Kuo Yu, Doctor principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patellar resurfacing with freehand technique and Patellar resurfacing with resection guide technique in people with Osteoarthritis, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 1 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 16 Jun 2017. 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 China. 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?
Patellar tilt (PT) (time frame: 1 year). 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 NCT02268097, which also lists 5 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 16 Jun 2017.