S83 S76
Conditions
Interventions
Group 1: Patients who have used an orthosis and Orthelligent in rehabilitation will receive 2 questionnaires on adherence, benefit assessment, safety, and current health status. The questionnaires are
Sponsors
OPED GmbH
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: Knee injury / damage to be treated within 6 months prior to use of the Orthelligent. - Use of the Orthelligent or patient with treatment of a knee joint injury with an orthosis of the manufacturer in the same period for the following indications: - Diabetes mell.: E11.40, E11.41 E14.40, E14.41, E14.80, E14.81, - (apoplexy) I61, I63, I64, I69, - Spinal muscular atrophy: G12.0/1/2/8/9 - Deg. Basal ganglia diseases: G23.0/2/3/8/9 - Multiple sclerosis: G35.0/1/2/3/10/11/20/21/30/31/9 - Hereditary and idiopathic neuropathy: G60.0/1/2/3/8/9 - Primary myopathies: G71 - Other myopathies: G72.0/1/2/3/4/8//9 - Infantile cerebral palsy: G80.1/2/3/4/8/9 - (hemiparesis) G81.0 /1/9 - Spinal cord damage: G82.6 - (disorders of the RM) G95, - Arthropathies: M00 - M25 (each for lower extremities) *.*5-*9 - Purulent arthritis: M00 (each for lower extremities) M00.*5-*9 - Direct joint infections in infectious and parasitic diseases classified elsewhere: (each for lower extremities) M01.*5-*9 - Reactive arthritides: (each for lower extremities) M03.*5-*9 - Inflammatory polyarthropathies (each for lower extremities) M05-14.*5-*9 - Polyarthrosis: M15.0/1/2/3/4/8/9 - Gonarthrosis: M17.0/1-5/9 - Other osteoarthritis: (each for lower extremities) M19.*5-*9 - Acquired deformities of extremities: (each for lower extremities) M21.*5-*9 - Diseases of the patella: M22.0-4/8/9 - Internal damage of knee joint: M23.* - Other more specifically described joint damage: M24.*5-*9 - Other joint disease, not elsewhere classified: (each for lower extremities) M25.*5-*9: (each for lower extremities) M13.*5-9 - Joint disease, not elsewhere classified: M25.05-09/15-19/25-29/35-39/45-49/55-59/65-69/75-79/85-89/95-99 - Systemic diseases of connective tissue in diseases classified elsewhere: M36.0/1/2/3/4/5* - Spondylopathies: M48.06/07/08/09/10/16/17/18/19/26-29/36-39/46-49/56-59/86-89/96-99 - Herniated disc: M51.0-4/8/9 - Other diseases of the spine and back, not elsewhere classified: M53.*6-*9 - Other muscular diseases: M62.06, M62.15/16/17, M62.25/26/27/28, M62.50/55/56/57/58/59; M62.65 - 69, M62.80/85-89, M62.90/95 -99 - Tendon rupture US: M66 - Gait complaints: R36.2 - (other NMS) R29.9, - Condition after ligament injuries knee joint (S83.40, S83.43, S83.44, S83.50, S83.53, S83.54, S83.; 5-813) - Condition after meniscal tears (S83.2; 5-812) - Condition after fractures near the knee (S72.4-, S82.0, S82.1-;5-78.-, 5-79.-, 5-80.-, 5-81) - Contusions knee/lower leg (S80.0, S80.1) - Condition after distortions knee joint (S83.41, S83.42, S83.51, S83.52, S83.6) - Condition after open injuries, thigh, knee, lower leg (superficial) (S71.1, S71.7, S80.7, S80.81, S80.82, S80.84, S80.88, S81.0, S81.9) - Condition after muscle or tendon injuries (thigh, lower leg) (S76.1, S76.2, S76.3, S76.4, S86.1, S86.2, S86.3, S86.7, S86.8, S86.9) - Condition after cartilage injuries knee joint (S83.3) - Condition after luxations patella/knee joint (S83.0, S83.1) - Signed informed consent form
Exclusion criteria
Exclusion criteria: In general: - Incapacity to consent. - Lack of understanding of explanation, informed consent, and study procedures Specific: - Diseases/injuries that also affect the contralateral side - Pronounced clinically relevant neurological diseases (degenerative, diabetic, ischemic, etc.) with influence on gait pattern - Muscular underlying diseases - Clinically relevant pAVK (from stage IIb according to Fontaine) - Restriction of the contralateral side - Further injuries or amputations of the lower extremities during the observation period - Influencing factors that no longer allow the assessment of rehabilitation measures on knee joint function - Less than 80% of the questions not answered or not answered plausibly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in adherence (commitment, motivation) in the group of patients with Orthelligent use compared to the group of patients from the same center with comparable knee joint damage but without Orthelligent use. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory: 1. safety, compliance, comfort, ease of use in 3 rehabilitation phases. 2. support for coordination of treatment processes 3. compliance with guidelines and accepted rehabilitation standards in 3 rehabilitation phases 4. promotion of self-responsibility 5. health competence 6. facilitation of access to care 7. medical benefits: improved rehabilitation outcomes 8. improvement in coping with disease-related difficulties in daily life 9. reduction of therapy-related efforts and burdens 10. satisfactory benefit/risk analysis with sufficient response rate and individual follow-up period 11. suitability for predicting the course of rehabilitation (time until resumption of daily activities/training/competition, time of training with bicycle ergometer) 12. number and timing of knee re-injuries (ipsi- or contralateral) 13. allocation of individual exercises to individual rehabilitation phases and, if applicable, desired rehabilitation goal 14. if necessary, subgroup analysis of particularly vulnerable groups (minors and > 65 years) 15. examination of equal distribution of the variables influencing adherence between the groups and, if necessary, correction of the adherence parameter for the influencing variables with group differences | — |
Countries
Germany
Contacts
Public ContactCaroline Schmidt - Lucke
Mediacc GmbH
Outcome results
None listed