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

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 Overview

• Status: Recruiting
• Conditions: Knee Deformity; Knee Disease
• Intervention / Treatment: Procedure: Arthroscopic posterior capsulotomy of the knee

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Konrad Malinowski, MD PhD; Phone Number: +48 509 812 212; Email: malwin8@wp.pl

Study Locations

• Poland
  • Bełchatów, Poland
    • Recruiting
    • Artromedical Orthopaedic Clinic
    • Contact: Konrad Malinowski, MD PhD; Phone Number: +48 509 812 212; Email: malwin8@wp.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arthroscopic posterior capsulotomy of the knee

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, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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

Collaborators and Investigators

• Sponsor: Artromedical Konrad Malinowski Clinic

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 30, 2021
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 1-pro-ar-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No