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

Primary Purpose

Knee Disease, Knee Deformity

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Arthroscopic posterior capsulotomy of the knee
Sponsored by
Artromedical Konrad Malinowski Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Artromedical Orthopaedic ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arthroscopic posterior capsulotomy of the knee

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

The flexion of the knee
The flexion of the knee will be measured with the goniometer with the patient lying supine.
The flexion of the knee
The flexion of the knee will be measured with the goniometer with the patient lying supine.
The flexion of the knee
The flexion of the knee will be measured with the goniometer with the patient lying supine.
The flexion of the knee
The flexion of the knee will be measured with the goniometer with the patient lying supine.
The flexion of the knee
The flexion of the knee will be measured with the goniometer with the patient lying supine.
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.
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.
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.
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.
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.
The functional assessment with the International Knee Documentation Committee Questionnaire
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the International Knee Documentation Committee Questionnaire
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the International Knee Documentation Committee Questionnaire
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the International Knee Documentation Committee Questionnaire
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the International Knee Documentation Committee Questionnaire
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome

Full Information

First Posted
October 30, 2021
Last Updated
July 21, 2023
Sponsor
Artromedical Konrad Malinowski Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05385393
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Artromedical Konrad Malinowski Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Disease, Knee Deformity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic posterior capsulotomy of the knee
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic posterior capsulotomy of the knee
Intervention Description
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.
Primary Outcome Measure Information:
Title
The extension of the knee
Description
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.
Time Frame
Immediately after the surgery.
Title
The extension of the knee
Description
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.
Time Frame
At the 3 month of the follow-up.
Title
The extension of the knee
Description
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.
Time Frame
At the 6 month of the follow-up.
Title
The extension of the knee
Description
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.
Time Frame
At the 12 month of the follow-up.
Title
The extension of the knee
Description
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.
Time Frame
At the 24 month of the follow-up.
Secondary Outcome Measure Information:
Title
The flexion of the knee
Description
The flexion of the knee will be measured with the goniometer with the patient lying supine.
Time Frame
Immediately after the surgery
Title
The flexion of the knee
Description
The flexion of the knee will be measured with the goniometer with the patient lying supine.
Time Frame
At the 3 month of the follow-up.
Title
The flexion of the knee
Description
The flexion of the knee will be measured with the goniometer with the patient lying supine.
Time Frame
At the 6 month of the follow-up.
Title
The flexion of the knee
Description
The flexion of the knee will be measured with the goniometer with the patient lying supine.
Time Frame
At the 12 month of the follow-up.
Title
The flexion of the knee
Description
The flexion of the knee will be measured with the goniometer with the patient lying supine.
Time Frame
At the 24 month of the follow-up.
Title
The range of motion of the knee
Description
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.
Time Frame
Immediately after the surgery
Title
The range of motion of the knee
Description
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.
Time Frame
At the 3 month of the follow-up.
Title
The range of motion of the knee
Description
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.
Time Frame
At the 6 month of the follow-up.
Title
The range of motion of the knee
Description
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.
Time Frame
At the 12 month of the follow-up.
Title
The range of motion of the knee
Description
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.
Time Frame
At the 24 month of the follow-up.
Title
The functional assessment with the International Knee Documentation Committee Questionnaire
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
Immediately after the surgery.
Title
The functional assessment with the International Knee Documentation Committee Questionnaire
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 3 month of the follow-up.
Title
The functional assessment with the International Knee Documentation Committee Questionnaire
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 6 month of the follow-up.
Title
The functional assessment with the International Knee Documentation Committee Questionnaire
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 12 month of the follow-up.
Title
The functional assessment with the International Knee Documentation Committee Questionnaire
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 24 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
Immediately after the surgery
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 3 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 6 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 12 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 24 month of the follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konrad Malinowski, MD PhD
Phone
+48 509 812 212
Email
malwin8@wp.pl
Facility Information:
Facility Name
Artromedical Orthopaedic Clinic
City
Bełchatów
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad Malinowski, MD PhD
Phone
+48 509 812 212
Email
malwin8@wp.pl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31917195
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.
Results Reference
background
PubMed Identifier
25511691
Citation
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.
Results Reference
background
PubMed Identifier
9046510
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.
Results Reference
background
PubMed Identifier
30533360
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.
Results Reference
background
PubMed Identifier
12585585
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.
Results Reference
background
PubMed Identifier
26875053
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.
Results Reference
background

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

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