Knee OsteoarthritisNCT04467970
Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.
A study testing Unicompartmental Knee Replacement and High Tibial Osteotomy in people with Knee Osteoarthritis and Knee Arthroplasty, run by Assiut University at 1 site in Egypt.
Trial summary
Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are established treatment options for patients with medial compartmental osteoarthritis (OA) of the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA have become subjects of debate. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthroplasty
- What is being tested?
- Unicompartmental Knee Replacement and High Tibial Osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 31 Mar 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Medial compartment osteoarthritis with exposed bone on both femur and tibia.
- -Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
- -Full thickness and good quality lateral cartilage present
- -Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5-Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2
Who cannot join
- Require revision knee replacement surgery.
- Have rheumatoid arthritis or other inflammatory disorders.
- Are unlikely to be able to perform required clinical assessment tasks.
- Have symptomatic foot, hip or spinal pathology.
- Previous knee surgery other than diagnostic arthroscopy and medial menisectomy.
- Previously had septic arthritis.
- Have significant damage to the patella-Femoral Joint especially on the lateral facet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy: A Randomized Controlled Trial
Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are established treatment options for patients with medial compartmental osteoarthritis (OA) of the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA have become subjects of debate.
Read the detailed description
Although HTO for the correction of malalignment in the medial osteoarthritic knee has been shown to provide successful outcomes in some studies, it is technically difficult to achieve the ideal valgus position postoperatively, and the likelihood of postoperative complications after HTO is greater than that after UKA . As compared with HTO, UKA has been reported to provide better long-term results, to have a shorter time to full weight bearing, to allow easier rehabilitation, and to have fewer perioperative complications. Furthermore, indications for UKA are broadening, including younger and more active patients, since encouraging midterm and long-term results were published.
- Conditions
- Knee Osteoarthritis, Knee Arthroplasty
- Being tested
- Unicompartmental Knee Replacement, High Tibial Osteotomy
- Keywords
- Unicompartmental knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicompartmental Knee ReplacementProcedure or surgery
Unicompartmental Knee Replacement involves replacement of the medial compartment of the knee in patients with anteromedial osteoarthritis.
High Tibial OsteotomyProcedure or surgery
High Tibial Osteotomy involves medial wedge opening high tibial osteotomy in cases of anteromedial osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Unicompartmental Knee Replacement | Experimental | Not described Receives: Procedure: Unicompartmental Knee Replacement |
| High Tibial Osteotomy | Experimental | Not described Receives: Procedure: High Tibial Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Function using Oxford Knee Score
this will be measured by using the Oxford Knee Score, a patient reported outcome questionnairewhich is A patient reported outcome measure highest score that could a patient get is 48 and means that good outcome and the lowest score to be obtained is 0 whick means poor outcome ( the higher the score,the better the outcome)
Measured: at least two year follow up.
Secondary outcomes (1)
Range of Motion and Function using the American Knee Society Score.
this will be measured using the American Knee Society Score (AKSS). A clinician assessed score examining pain, stability, range of movement and function in which the maximum score to get is 100 and least score to get is 0 and the higher the score the better the outcome.
Measured: at least two year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Oct 2020
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Anter Ali Abdelhameed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467970
- Sponsor's protocol ID
- UKAVSHTOARCT
- Status last verified
- May 2024
- First submitted
- 6 Jul 2020
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04467970
- Acronym / sponsor ID
- UKAVSHTOARCT
- Conditions
- Knee Osteoarthritis, Knee Arthroplasty
- Keywords
- Unicompartmental knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 13 Jul 2020 (actual)
- 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.
Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are established treatment options for patients with medial compartmental osteoarthritis (OA) of the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA have become subjects of debate.
Detailed description
Although HTO for the correction of malalignment in the medial osteoarthritic knee has been shown to provide successful outcomes in some studies, it is technically difficult to achieve the ideal valgus position postoperatively, and the likelihood of postoperative complications after HTO is greater than that after UKA . As compared with HTO, UKA has been reported to provide better long-term results, to have a shorter time to full weight bearing, to allow easier rehabilitation, and to have fewer perioperative complications. Furthermore, indications for UKA are broadening, including younger and more active patients, since encouraging midterm and long-term results were published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unicompartmental Knee Replacement | Experimental | Procedure: Unicompartmental Knee Replacement |
| High Tibial Osteotomy | Experimental | Procedure: High Tibial Osteotomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Medial compartment osteoarthritis with exposed bone on both femur and tibia.
- -Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
- -Full thickness and good quality lateral cartilage present
- -Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5-Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2
Key exclusion criteria (7 listed)
- Require revision knee replacement surgery.
- Have rheumatoid arthritis or other inflammatory disorders.
- Are unlikely to be able to perform required clinical assessment tasks.
- Have symptomatic foot, hip or spinal pathology.
- Previous knee surgery other than diagnostic arthroscopy and medial menisectomy.
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 |
|---|---|---|
| Unicompartmental Knee ReplacementUnicompartmental Knee Replacement involves replacement of the medial compartment of the knee in patients with anteromedial osteoarthritis. | Procedure or surgery | Unicompartmental Knee Replacement |
| High Tibial OsteotomyHigh Tibial Osteotomy involves medial wedge opening high tibial osteotomy in cases of anteromedial osteoarthritis. | Procedure or surgery | High Tibial Osteotomy |
Primary outcome
Pain and Function using Oxford Knee Score
Time frame: at least two year follow up.
this will be measured by using the Oxford Knee Score, a patient reported outcome questionnairewhich is A patient reported outcome measure highest score that could a patient get is 48 and means that good outcome and the lowest score to be obtained is 0 whick means poor outcome ( the higher the score,the better the outcome)
1 secondary outcome
Range of Motion and Function using the American Knee Society Score.
Time frame: at least two year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unicompartmental Knee Replacement and High Tibial Osteotomy in people with Knee Osteoarthritis and Knee Arthroplasty, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 7 May 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain and Function using Oxford Knee Score (time frame: at least two year follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.