Knee DiseaseNCT05385393
Functional Outcomes and the Restoration of Range of Motion After the Arthroscopic Complete Posterior Knee Capsulotomy in Patients With Extension Deficit of the Knee
A study testing Arthroscopic posterior capsulotomy of the knee in people with Knee Disease and Knee Deformity, run by Artromedical Konrad Malinowski Clinic at 1 site in Poland.
Trial summary
The restriction of the range of motion is one of the most frequently encountered complications after the surgical procedures of the knee. While the flexion deficit is relatively well tolerated, even the small extension deficit significantly impairs the quality of life due to the increased stress on the patellofemoral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Disease, Knee Deformity
- What is being tested?
- Arthroscopic posterior capsulotomy of the knee
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2020to 1 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years old,
- Symptomatic asymmetric extension deficit >3 degrees,
- Impossibility to restore the full knee extension after 6 months of guided physiotherapy.
Who cannot join
- Restoration of full knee extension after the initial knee arthrolysis,
- Active knee inflammation,
- Non-adherence of the patient to the treatment protocol.
- Contractures due to extra-articular reasons,
- Less than 6 months since the last surgical procedure affected knee.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Artromedical Orthopaedic Clinic
Bełchatów
Konrad Malinowski, MD PhD, +48 509 812 212, malwin8@wp.pl
About this study
The restriction of the range of motion is one of the most frequently encountered complications after the surgical procedures of the knee. While the flexion deficit is relatively well tolerated, even the small extension deficit significantly impairs the quality of life due to the increased stress on the patellofemoral joint, functional leg length discrepancy and the subsequent mechanical overload in the hip joint, lumbar spine and contralateral knee. In the majority of cases the guided physiotherapy protocol is sufficient to restore the full range of motion. In refractory cases, the treatment consists of the thorough arthrolysis of the affected knee, aiming to excise the adhesions, osteophytes and orthopaedic implants interfering with the knee range of motion. However, as the extension deficit persists, the contracture of the knee posterior capsule may develop and the sole debridement of the knee may be insufficient. In such rare cases the treatment consists of the posterior capsulotomy of the affected joint. Traditionally, this procedure was performed through the open approach. However, with the growing indications toward the arthroscopic procedures seen in recent decades, even such salvage procedures like posterior knee capsulotomy are increasingly performed through the arthroscopic approach. The aim of this study is to assess the outcomes of the arthroscopic complete posterior capsulotomy of the knee basing on the knee range of motion and functional outcomes. The primary outcome consists of the knee extension, whereas the secondary outcomes include knee flexion, knee total range of motion, The International Knee Documentation Committee Questionnaire and the Knee injury and Osteoarthritis Outcome Score.
- Conditions
- Knee Disease, Knee Deformity
- Being tested
- Arthroscopic posterior capsulotomy of the knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic posterior capsulotomy of the kneeProcedure or surgery
The arthroscopic posterior capsulotomy of the knee is performed according to the predefined surgical technique, which was described in detail in the following publication:
Malinowski K, Góralczyk A, Hermanowicz K, LaPrade RF, Więcek R, Domżalski ME. Arthroscopic Complete Posterior Capsulotomy for Knee Flexion Contracture. Arthrosc Tech. 2018 Oct 15;7(11):e1135-e1139. doi: 10.1016/j.eats.2018.07.008. PMID: 30533360; PMCID: PMC6262078.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic posterior capsulotomy of the knee | Experimental | Not described Receives: Procedure: Arthroscopic posterior capsulotomy of the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extension of the knee
The extension of the knee will be measured with the goniometer with the patient lying supine. The hyperextension of the knee will be denoted as the negative value of knee extension.
Measured: Immediately after the surgery.
The extension of the knee
The extension of the knee will be measured with the goniometer with the patient lying supine. The hyperextension of the knee will be denoted as the negative value of knee extension.
Measured: At the 3 month of the follow-up.
The extension of the knee
The extension of the knee will be measured with the goniometer with the patient lying supine. The hyperextension of the knee will be denoted as the negative value of knee extension.
Measured: At the 6 month of the follow-up.
The extension of the knee
The extension of the knee will be measured with the goniometer with the patient lying supine. The hyperextension of the knee will be denoted as the negative value of knee extension.
Measured: At the 12 month of the follow-up.
The extension of the knee
The extension of the knee will be measured with the goniometer with the patient lying supine. The hyperextension of the knee will be denoted as the negative value of knee extension.
Measured: At the 24 month of the follow-up.
Secondary outcomes (20)
The flexion of the knee
The flexion of the knee will be measured with the goniometer with the patient lying supine.
Measured: Immediately after the surgery
The flexion of the knee
The flexion of the knee will be measured with the goniometer with the patient lying supine.
Measured: At the 3 month of the follow-up.
The flexion of the knee
The flexion of the knee will be measured with the goniometer with the patient lying supine.
Measured: At the 6 month of the follow-up.
The flexion of the knee
The flexion of the knee will be measured with the goniometer with the patient lying supine.
Measured: At the 12 month of the follow-up.
The flexion of the knee
The flexion of the knee will be measured with the goniometer with the patient lying supine.
Measured: At the 24 month of the follow-up.
The range of motion of the knee
The range of motion of the knee will be measured with the goniometer with the patient lying supine as a difference between knee flexion and knee extension.
Measured: Immediately after the surgery
The range of motion of the knee
The range of motion of the knee will be measured with the goniometer with the patient lying supine as a difference between knee flexion and knee extension.
Measured: At the 3 month of the follow-up.
The range of motion of the knee
The range of motion of the knee will be measured with the goniometer with the patient lying supine as a difference between knee flexion and knee extension.
Measured: At the 6 month of the follow-up.
The range of motion of the knee
The range of motion of the knee will be measured with the goniometer with the patient lying supine as a difference between knee flexion and knee extension.
Measured: At the 12 month of the follow-up.
The range of motion of the knee
The range of motion of the knee will be measured with the goniometer with the patient lying supine as a difference between knee flexion and knee extension.
Measured: At the 24 month of the follow-up.
The functional assessment with the International Knee Documentation Committee Questionnaire
Min of 0 max of 87 points, higher scores mean a better outcome
Measured: Immediately after the surgery.
The functional assessment with the International Knee Documentation Committee Questionnaire
Min of 0 max of 87 points, higher scores mean a better outcome
Measured: At the 3 month of the follow-up.
The functional assessment with the International Knee Documentation Committee Questionnaire
Min of 0 max of 87 points, higher scores mean a better outcome
Measured: At the 6 month of the follow-up.
The functional assessment with the International Knee Documentation Committee Questionnaire
Min of 0 max of 87 points, higher scores mean a better outcome
Measured: At the 12 month of the follow-up.
The functional assessment with the International Knee Documentation Committee Questionnaire
Min of 0 max of 87 points, higher scores mean a better outcome
Measured: At the 24 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
Measured: Immediately after the surgery
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
Measured: At the 3 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
Measured: At the 6 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
Measured: At the 12 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
Measured: At the 24 month of the follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Jun 2020
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Knee DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artromedical Konrad Malinowski Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385393
- Sponsor's protocol ID
- 1-pro-ar-2021
- Status last verified
- Jul 2023
- First submitted
- 30 Oct 2021
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Campbell TM, Trudel G. Knee Flexion Contracture Associated With a Contracture and Worse Function of the Contralateral Knee: Data From the Osteoarthritis Initiative. Arch Phys Med Rehabil. 2020 Apr;101(4):624-632. doi: 10.1016/j.apmr.2019.11.018. Epub 2020 Jan 7.
PubMed 31917195Campbell TM, Trudel G, Laneuville O. Knee flexion contractures in patients with osteoarthritis: clinical features and histologic characterization of the posterior capsule. PM R. 2015 May;7(5):466-73. doi: 10.1016/j.pmrj.2014.12.001. Epub 2014 Dec 12.
PubMed 25511691Lobenhoffer HP, Bosch U, Gerich TG. Role of posterior capsulotomy for the treatment of extension deficits of the knee. Knee Surg Sports Traumatol Arthrosc. 1996;4(4):237-41. doi: 10.1007/BF01567970.
PubMed 9046510Malinowski K, Goralczyk A, Hermanowicz K, LaPrade RF, Wiecek R, Domzalski ME. Arthroscopic Complete Posterior Capsulotomy for Knee Flexion Contracture. Arthrosc Tech. 2018 Oct 15;7(11):e1135-e1139. doi: 10.1016/j.eats.2018.07.008. eCollection 2018 Nov.
PubMed 30533360Murata Y, Takahashi K, Yamagata M, Hanaoka E, Moriya H. The knee-spine syndrome. Association between lumbar lordosis and extension of the knee. J Bone Joint Surg Br. 2003 Jan;85(1):95-9. doi: 10.1302/0301-620x.85b1.13389.
PubMed 12585585Tardy N, Thaunat M, Sonnery-Cottet B, Murphy C, Chambat P, Fayard JM. Extension deficit after ACL reconstruction: Is open posterior release a safe and efficient procedure? Knee. 2016 Jun;23(3):465-71. doi: 10.1016/j.knee.2016.01.001. Epub 2016 Feb 11.
PubMed 26875053Malinowski K, Mostowy M, Kozlak M, Pekala PA, Kennedy NI, LaPrade RF. Complete Arthroscopic Posterior Knee Capsulotomy in Patients With Knee Extension Deficit: Preliminary Results of a Clinical Trial. Orthop J Sports Med. 2023 Dec 1;11(12):23259671231203606. doi: 10.1177/23259671231203606. eCollection 2023 Dec.
PubMed 38045767
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes and the Restoration of Range of Motion After the Arthroscopic Complete Posterior Knee Capsulotomy in Patients With Extension Deficit of the Knee
- ClinicalTrials.gov ID
- NCT05385393
- Acronym / sponsor ID
- 1-pro-ar-2021
- Conditions
- Knee Disease, Knee Deformity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Artromedical Konrad Malinowski ClinicUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 May 2022 (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.
The restriction of the range of motion is one of the most frequently encountered complications after the surgical procedures of the knee. While the flexion deficit is relatively well tolerated, even the small extension deficit significantly impairs the quality of life due to the increased stress on the patellofemoral joint, functional leg length discrepancy and the subsequent mechanical overload in the hip joint, lumbar spine and contralateral knee. In the majority of cases the guided physiotherapy protocol is sufficient to restore the full range of motion. In refractory cases, the treatment consists of the thorough arthrolysis of the affected knee, aiming to excise the adhesions, osteophytes and orthopaedic implants interfering with the knee range of motion. However, as the extension deficit persists, the contracture of the knee posterior capsule may develop and the sole debridement of the knee may be insufficient. In such rare cases the treatment consists of the posterior capsulotomy of the affected joint. Traditionally, this procedure was performed through the open approach. However, with the growing indications toward the arthroscopic procedures seen in recent decades, even such salvage procedures like posterior knee capsulotomy are increasingly performed through the arthroscopic approach. The aim of this study is to assess the outcomes of the arthroscopic complete posterior capsulotomy of the knee basing on the knee range of motion and functional outcomes. The primary outcome consists of the knee extension, whereas the secondary outcomes include knee flexion, knee total range of motion, The International Knee Documentation Committee Questionnaire and the Knee injury and Osteoarthritis Outcome Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic posterior capsulotomy of the knee | Experimental | Procedure: Arthroscopic posterior capsulotomy of the knee |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 18 years old,
- Symptomatic asymmetric extension deficit >3 degrees,
- Impossibility to restore the full knee extension after 6 months of guided physiotherapy.
Key exclusion criteria (5 listed)
- Restoration of full knee extension after the initial knee arthrolysis,
- Active knee inflammation,
- Non-adherence of the patient to the treatment protocol.
- Contractures due to extra-articular reasons,
- Less than 6 months since the last surgical procedure affected knee.
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 |
|---|---|---|
| Arthroscopic posterior capsulotomy of the kneeThe arthroscopic posterior capsulotomy of the knee is performed according to the predefined surgical technique, which was described in detail in the following publication: Malinowski K, Góralczyk A, Hermanowicz K, LaPrade RF, Więcek R, Domżalski ME. Arthroscopic Complete Posterior Capsulotomy for Knee Flexion Contracture. Arthrosc Tech. 2018 Oct 15;7(11):e1135-e1139. doi: 10.1016/j.eats.2018.07.008. PMID: 30533360; PMCID: PMC6262078. | Procedure or surgery | Arthroscopic posterior capsulotomy of the knee |
Primary outcome
The extension of the knee
Time frame: Immediately after the surgery.
The extension of the knee will be measured with the goniometer with the patient lying supine. The hyperextension of the knee will be denoted as the negative value of knee extension.
The extension of the knee
Time frame: At the 3 month of the follow-up.
The extension of the knee will be measured with the goniometer with the patient lying supine. The hyperextension of the knee will be denoted as the negative value of knee extension.
The extension of the knee
Time frame: At the 6 month of the follow-up.
The extension of the knee will be measured with the goniometer with the patient lying supine. The hyperextension of the knee will be denoted as the negative value of knee extension.
The extension of the knee
Time frame: At the 12 month of the follow-up.
The extension of the knee will be measured with the goniometer with the patient lying supine. The hyperextension of the knee will be denoted as the negative value of knee extension.
The extension of the knee
Time frame: At the 24 month of the follow-up.
The extension of the knee will be measured with the goniometer with the patient lying supine. The hyperextension of the knee will be denoted as the negative value of knee extension.
20 secondary outcomes
The flexion of the knee
Time frame: Immediately after the surgery
The flexion of the knee
Time frame: At the 3 month of the follow-up.
The flexion of the knee
Time frame: At the 6 month of the follow-up.
The flexion of the knee
Time frame: At the 12 month of the follow-up.
The flexion of the knee
Time frame: At the 24 month of the follow-up.
The range of motion of the knee
Time frame: Immediately after the surgery
The range of motion of the knee
Time frame: At the 3 month of the follow-up.
The range of motion of the knee
Time frame: At the 6 month of the follow-up.
The range of motion of the knee
Time frame: At the 12 month of the follow-up.
The range of motion of the knee
Time frame: At the 24 month of the follow-up.
The functional assessment with the International Knee Documentation Committee Questionnaire
Time frame: Immediately after the surgery.
The functional assessment with the International Knee Documentation Committee Questionnaire
Time frame: At the 3 month of the follow-up.
The functional assessment with the International Knee Documentation Committee Questionnaire
Time frame: At the 6 month of the follow-up.
The functional assessment with the International Knee Documentation Committee Questionnaire
Time frame: At the 12 month of the follow-up.
The functional assessment with the International Knee Documentation Committee Questionnaire
Time frame: At the 24 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: Immediately after the surgery
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: At the 3 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: At the 6 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: At the 12 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: At the 24 month of the follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 31917195Campbell TM, Trudel G. Knee Flexion Contracture Associated With a Contracture and Worse Function of the Contralateral Knee: Data From the Osteoarthritis Initiative. Arch Phys Med Rehabil. 2020 Apr;101(4):624-632. doi: 10.1016/j.apmr.2019.11.018. Epub 2020 Jan 7.
- Background: PubMed 25511691Campbell TM, Trudel G, Laneuville O. Knee flexion contractures in patients with osteoarthritis: clinical features and histologic characterization of the posterior capsule. PM R. 2015 May;7(5):466-73. doi: 10.1016/j.pmrj.2014.12.001. Epub 2014 Dec 12.
- Background: PubMed 9046510Lobenhoffer HP, Bosch U, Gerich TG. Role of posterior capsulotomy for the treatment of extension deficits of the knee. Knee Surg Sports Traumatol Arthrosc. 1996;4(4):237-41. doi: 10.1007/BF01567970.
- Background: PubMed 30533360Malinowski K, Goralczyk A, Hermanowicz K, LaPrade RF, Wiecek R, Domzalski ME. Arthroscopic Complete Posterior Capsulotomy for Knee Flexion Contracture. Arthrosc Tech. 2018 Oct 15;7(11):e1135-e1139. doi: 10.1016/j.eats.2018.07.008. eCollection 2018 Nov.
- Background: PubMed 12585585Murata Y, Takahashi K, Yamagata M, Hanaoka E, Moriya H. The knee-spine syndrome. Association between lumbar lordosis and extension of the knee. J Bone Joint Surg Br. 2003 Jan;85(1):95-9. doi: 10.1302/0301-620x.85b1.13389.
- Background: PubMed 26875053Tardy N, Thaunat M, Sonnery-Cottet B, Murphy C, Chambat P, Fayard JM. Extension deficit after ACL reconstruction: Is open posterior release a safe and efficient procedure? Knee. 2016 Jun;23(3):465-71. doi: 10.1016/j.knee.2016.01.001. Epub 2016 Feb 11.
- Derived from this study: PubMed 38045767Malinowski K, Mostowy M, Kozlak M, Pekala PA, Kennedy NI, LaPrade RF. Complete Arthroscopic Posterior Knee Capsulotomy in Patients With Knee Extension Deficit: Preliminary Results of a Clinical Trial. Orthop J Sports Med. 2023 Dec 1;11(12):23259671231203606. doi: 10.1177/23259671231203606. eCollection 2023 Dec.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic posterior capsulotomy of the knee in people with Knee Disease and Knee Deformity, run by Artromedical Konrad Malinowski Clinic at 1 site in Poland.
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 3 inclusion and 5 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 24 Jul 2023. 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 Poland. 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?
Contact Konrad Malinowski, MD PhD (+48 509 812 212, malwin8@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The extension of the knee (time frame: Immediately after the surgery.). The study lists 5 primary outcomes in all. 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 NCT05385393, which also lists 7 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 24 Jul 2023.