NCT06644092

Brief Summary

The aim of our study is to add to the literature the effect of the effectiveness of the physiotherapy and rehabilitation in the clinic, which will be applied to the patients after the osteochondral allograft transplantation operation, which is a current treatment approach applied after knee cartilage tissue damage, on the range of motion, functionality, pain and muscle strength of the patients during the recovery process. The clinical importance of our aim is that it will have the potential to guide health professionals in determining the appropriate treatment approach in order to reveal the best results that can be obtained due to the lack of many studies in the literature on the treatment of patients after osteochondral allograft surgery.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2025

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

October 10, 2024

Last Update Submit

October 15, 2024

Conditions

Keywords

Physical TherapyOsteochondral Allograft TransplantationOsteochondral LesionCartilage Damage

Outcome Measures

Primary Outcomes (2)

  • KOOS

    Knee Injury and Osteoarthritis Outcome Score (KOOS): A health measure used to evaluate knee injuries and knee-related conditions such as osteoarthritis. The KOOS comes in a widely used questionnaire format to assess patients' knee function, pain, quality of life, and other symptoms. By measuring problems in subcategories such as pain, symptoms, quality of life, functional limitations, and sports/dialysis activities, it provides healthcare professionals with an important tool to monitor patients' response to treatment, evaluate treatment plans, and understand patients' quality of life.

    6 months

  • Oxford Knee Scale

    The Oxford Knee Score (ODS) is a valid and reliable questionnaire with a Turkish version that allows individuals with knee OA to assess their own function and pain. It is scored on a Likert scale from 0 (absent) to 4 (severe) (0-48). In this questionnaire consisting of 12 questions, questions 2, 3, 7, 11 and 12 assess functional status; questions 1, 4, 5, 6, 8, 9 and 10 assess pain-related status. Scores from ODS pain questions range from 0 to 28 points, with the lowest score being 0 and the highest score being 28. Scores from ODS function 30 parameters range from 0 to 20 points, with the lowest score being 0 and the highest score being 20. High scores indicate worse functional status and pain.

    6 months

Study Arms (1)

Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft

EXPERIMENTAL

The question of our research is to determine the effectiveness of the physiotherapy and rehabilitation protocol applied in the postoperative period on the knee joint range of motion, functionality, muscle strength around the knee joint (quadriceps/hamstring ratio) and pain parameters in patients who underwent osteochondral allograft transplantation surgery and to include it in the literature. In this direction, the hypotheses of our study are; H0: The physical therapy and rehabilitation protocol to be applied after osteochondral allograft transplantation surgery has a positive contribution to the patient's knee joint range of motion, functionality, muscle strength and pain. H1: The physical therapy and rehabilitation protocol to be applied after osteochondral allograft transplantation surgery does not have a positive contribution to the patient's knee joint range of motion, functionality, muscle strength and pain.

Other: Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation

Interventions

The treatment protocol to be applied to the patients after surgery was determined. The protocol includes; cold application, game ready device application, CPM device application, patellar mobilization, soft tissue mobilization application, TENS, conventional TENS and NMES application, ultrasound application, stretching exercises, strengthening exercises, mobilization exercises, balance and proprioception exercises, walking training and kinesio taping.

Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent osteochondral allograft transplantation surgery Participant's acceptance/desire to participate in the study

You may not qualify if:

  • Patient participant's refusal/desire to participate in the study Inability to perform exercises due to infection etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University Hospital

Istanbul, Atasehir, 34000, Turkey (Türkiye)

Location

Related Publications (1)

  • 1. Nho SJ, Pensak MJ, Seigerman DA, Cole BJ. Rehabilitation after autologous chondrocyte implantation in athletes. Clinics in sports medicine. 2010 Apr 1;29(2):267-82. 2. Flanigan DC, Harris JD, Trinh TQ, Siston RA, Brophy RH. Prevalence of chondral defects in athletes' knees: a systematic review. Med Sci Sports Exerc. 2010 Oct 1;42(10):1795-801. 3. Moyad TF. Cartilage injuries in the adult knee: evaluation and management. Cartilage. 2011 Jul;2(3):226-36. 4. Hjelle K, Solheim E, Strand T, Muri R, Brittberg M. Articular cartilage defects in 1,000 knee arthroscopies. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2002 Sep 1;18(7):730-4. 5. Chimutengwende-Gordon M, Donaldson J, Bentley G. Current solutions for the treatment of chronic articular cartilage defects in the knee. EFORT open reviews. 2020 Mar 2;5(3):156-63. 6. Berta Á, Duska Z, Tóth F, Hangody L. Clinical experiences with cartilage repair techniques: outcomes, indications, contraindications and rehabilitation. Joint Diseases and Related Surgery. 2015;26(2):084-96. 7. Cole BJ, Haunschild ED, Carter T, Meyer J, Fortier LA, Gilat R, ... & Pace JL. Clinically significant outcomes following the treatment of focal cartilage defects of the knee with microfracture augmentation using cartilage allograft extracellular matrix: a multicenter prospective study. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2021 May;37(5):1512-1521. 8. Vogt S, Angele P, Arnold M, Brehme K, Cotic M, Haasper C, Hinterwimmer S, Imhoff AB, Petersen W, Salzmann G, Steinwachs M. Practice in rehabilitation after cartilage therapy: an expert survey. Archives of orthopaedic and trauma surgery. 2013 Mar;133:311-20. 9. Krych AJ, Saris DB, Stuart MJ, Hacken B. Cartilage injury in the knee: assessment and treatment options. JAAOS-Journal of the American Academy of Orthopaedic Surgeons. 2020 Nov;28(22):914-922. 10. Crowley SG, Pedersen A, Fortney TA, Swindell HW, Saltzman BM, Popkin CA, Trofa DP. Rehabilitation variability fo

    BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yeditepe University

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 16, 2024

Study Start

October 9, 2024

Primary Completion

April 9, 2025

Study Completion

May 9, 2025

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations