Functional Outcomes and the Restoration of Range of Motion After the Arthroscopic Complete Posterior Knee Capsulotomy in Patients With Extension Deficit of the Knee

Knee Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385393
• Other study ID #: 1-pro-ar-2021
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: July 2023
• Source: Artromedical Konrad Malinowski Clinic
• Contact: Konrad Malinowski, MD PhD
• Phone: +48 509 812 212
• Email: malwin8[@]wp.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18 years old,

• Symptomatic asymmetric extension deficit >3 degrees,

• Impossibility to restore the full knee extension after 6 months of guided physiotherapy.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Knee Deformity
• Knee Disease

Intervention

Procedure:
• Arthroscopic posterior capsulotomy of the knee
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, 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. PMID: 30533360; PMCID: PMC6262078.

Locations

Country	Name	City	State
Poland	Artromedical Orthopaedic Clinic	Belchatów

Sponsors (1)

Lead Sponsor	Collaborator
Artromedical Konrad Malinowski Clinic

Country where clinical trial is conducted

Poland, 

References & Publications (6)

Campbell 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. — View Citation

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. — View Citation

Lobenhoffer 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. — View Citation

Malinowski 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. — View Citation

Murata 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. — View Citation

Tardy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after the surgery.
Primary	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.	At the 3 month of the follow-up.
Primary	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.	At the 6 month of the follow-up.
Primary	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.	At the 12 month of the follow-up.
Primary	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.	At the 24 month of the follow-up.
Secondary	The flexion of the knee	The flexion of the knee will be measured with the goniometer with the patient lying supine.	Immediately after the surgery
Secondary	The flexion of the knee	The flexion of the knee will be measured with the goniometer with the patient lying supine.	At the 3 month of the follow-up.
Secondary	The flexion of the knee	The flexion of the knee will be measured with the goniometer with the patient lying supine.	At the 6 month of the follow-up.
Secondary	The flexion of the knee	The flexion of the knee will be measured with the goniometer with the patient lying supine.	At the 12 month of the follow-up.
Secondary	The flexion of the knee	The flexion of the knee will be measured with the goniometer with the patient lying supine.	At the 24 month of the follow-up.
Secondary	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.	Immediately after the surgery
Secondary	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.	At the 3 month of the follow-up.
Secondary	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.	At the 6 month of the follow-up.
Secondary	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.	At the 12 month of the follow-up.
Secondary	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.	At the 24 month of the follow-up.
Secondary	The functional assessment with the International Knee Documentation Committee Questionnaire	Min of 0 max of 87 points, higher scores mean a better outcome	Immediately after the surgery.
Secondary	The functional assessment with the International Knee Documentation Committee Questionnaire	Min of 0 max of 87 points, higher scores mean a better outcome	At the 3 month of the follow-up.
Secondary	The functional assessment with the International Knee Documentation Committee Questionnaire	Min of 0 max of 87 points, higher scores mean a better outcome	At the 6 month of the follow-up.
Secondary	The functional assessment with the International Knee Documentation Committee Questionnaire	Min of 0 max of 87 points, higher scores mean a better outcome	At the 12 month of the follow-up.
Secondary	The functional assessment with the International Knee Documentation Committee Questionnaire	Min of 0 max of 87 points, higher scores mean a better outcome	At the 24 month of the follow-up.
Secondary	The functional assessment with the Knee injury and Osteoarthritis Outcome Score	Min of 0 max of 100 points, higher scores mean a better outcome	Immediately after the surgery
Secondary	The functional assessment with the Knee injury and Osteoarthritis Outcome Score	Min of 0 max of 100 points, higher scores mean a better outcome	At the 3 month of the follow-up.
Secondary	The functional assessment with the Knee injury and Osteoarthritis Outcome Score	Min of 0 max of 100 points, higher scores mean a better outcome	At the 6 month of the follow-up.
Secondary	The functional assessment with the Knee injury and Osteoarthritis Outcome Score	Min of 0 max of 100 points, higher scores mean a better outcome	At the 12 month of the follow-up.
Secondary	The functional assessment with the Knee injury and Osteoarthritis Outcome Score	Min of 0 max of 100 points, higher scores mean a better outcome	At the 24 month of the follow-up.