An interventional study of C-Brace and KAFO/SCO in Pareses, Lower Extremity, sponsored by Otto Bock Healthcare Products GmbH. Completed at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Otto Bock Healthcare Products GmbH · Not applicable, Interventional, and Treatment
Prospective, international, multi-center, open-labeled, randomized, controlled cross-over trial to evaluate effectiveness and benefits in patients with lower limb impairment in activities of daily living comparing the C-Brace microprocessor-controlled stance and swing orthosis to standard of care use of knee ankle foot orthosis/stance control orthoses
After obtaining informed consent, patients will be screened. For subjects fulfilling inclusion/exclusion criteria, a first baseline assessment will be conducted. Within one to two days, a second set of baseline data will be collected for performance measures. Subjects will then be randomly assigned to be fitted with C-Brace or to continue wearing the current KAFO/SCO. After fitting, an accommodation period follows that will last up to 14 days prior to the initial home use. The first follow-up data collection will occur after three months of the initial home use period. Afterwards, the patients will cross over to KAFO/SCO or C-Brace, respectively. The participants who were fitted with C-Brace will cross over to KAFO/SCO and vice versa. Another accommodation phase will be offered for both C-Brace and KAFO/SCO wearers to ensure that subjects can properly use both devices before the cross-over home use period. The second follow-up data collection will occur after 3-months of the cross-over home use period. At the end of the study, the patients can choose to keep the C-Brace for up to 24 months until reimbursement or to return to their original KAFO/SCO.
468 studies on the registry are indexed under Paresis; 117 are open to participants now.
This study's enrollment of 149 is above the median of 37 across 420 interventional studies indexed under Paresis.
Browse Paresis studies →Otto Bock Healthcare Products GmbH is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
Device: KAFO/SCO
Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
Device: C-Brace
The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
Also known as: Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO)
Current knee ankle foot orthosis that the subject was wearing at baseline
Also known as: Locked KAFO, Posterior offset KAFO, Stance Control Orthosis
Primary Efficacy: Berg Balance Scale (BBS)
The Berg Balance Scale is a 14-item scale designed to measure static and dynamic balance in adults in a clinical setting. The range in score for the BBS is 0 to 56, with higher scores indicating better balance. Points for each item are deducted if the time or distance requirements are not met, the patient's performance requires supervision, or the patient requires assistance from support or examiner.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Activity-specific Balance Confidence (ABC) Scale
Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Dynamic Gait Index (DGI)
An 8-item test used to assess balance during walking tasks. It has a maximum score of 24 with each item being scored 0-3. A higher score indicates greater balance, and subjects lose a a point on all items for which an assistive device is needed.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
6-minute Walk Test
Distance walked in 6 minutes over 12-meter back-and-forth pathway as a measure of functional exercise capacity.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Stair Assessment Index (SAI) - Down
A 14-point ordinal scale (0 - 13) used to assess different gait patterns during descent of stairs. The range of total scores for the SAI is from 0 to 26, with a higher score indicating a more normative gait pattern and needing less assistance.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Frequency of Falling
Frequency of falling by using C-Brace compared to KAFO/SCO as measured by the number of falls in 3-month period by recollection at baseline and recorded in a Falls Diary during home-use periods
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Fear of Falling
Two questions on patients' fear of falling indoors and outdoors based on an 11-point scale (0 = no fear, 10 = max. fear). The total score will range from 0 to 20, with 20 being maximum fear of falling.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO
Proportion of subjects having reported falling more than once will be compared between KAFO and C-Brace home-use periods
Time frame: 3 months after initial home use period, and 3 months after cross-over home use period
Reintegration to Normal Living (RNL) Index Questionnaire
11 items measuring satisfaction regarding perceived physical functioning, and social and emotional life. Higher scores represent higher levels of participation. The range of the adjusted total score is 0 to 100.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
EQ-5D-5L
Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). The raw score is then aggregated and normalized based on region to a 0 to 1 scale (where 0 represents maximum issues and 1 represents no problems).
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Work Limitations Questionnaires WLQ-25
25-item questionnaire to evaluate at-work disability and productivity loss under four sub-scales: time demands, physical demands, mental/interpersonal demands, and output demands. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time).
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Orthotics & Prosthetics User Survey (OPUS)
A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services. Three of the five domains will be administered: lower extremity functional status (20 items, score ranges from 0 - 80, with high score being easier), health-related quality of life index (23 items, score ranges from 0 - 92, with higher score being better) and satisfaction with device (11 items, score ranges from 11 - 55, with higher score being more satisfaction) scales. The domains of upper limb functional measure and satisfaction with service are not applicable in this study.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Medical Outcomes Study Short Form (SF-36)
36-item scale constructed to survey health status and quality of life. It assesses eight health concept scales: physical functioning, role functioning/physical, role functioning/emotional, energy/fatigue, emotional well-being, social functioning, pain and general health. Each scale score ranges from 0 to 100 with 100 being the highest (better) score.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST)
12-item instrument used to assess satisfaction with a specific assistive device. Each questions is rated on a 5-point scale, with 1=not satisfied at all and 5=very satisfied. The first 8 questions comprise the Device subscale and the last 4, the Services subscale. Each subscale and the total score are presented as averages ranging from 1 to 5, with higher scores representing greater satisfaction.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Patient-Related Outcome Questions
Two questions asking how the specific orthoses affected activities they enjoy and their quality of life. Each question is on a 5-point scale, with 1=much worse and 5=much better.
Time frame: 3 months after cross-over home use period
Potential participants were pre-screened based on their medical and/or orthotic records. After signing a written informed consent, participants were screened for inclusion and exclusion criteria. The screening process comprised a thorough patient evaluation and a test with the functional C-Brace trial tool to check whether the potential study participant was able to initiate swing and utilize controlled knee flexion during weight bearing.
| Milestone | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO |
|---|---|---|
| Started | 52 | 50 |
| Completed | 50 | 47 |
| Not completed | 2 | 3 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lack of access to site during covid | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Milestone | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO |
|---|---|---|
| Started | 50 | 47 |
| Completed | 47 | 44 |
| Not completed | 3 | 3 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Milestone | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO |
|---|---|---|
| Started | 47 | 44 |
| Completed | 41 | 43 |
| Not completed | 6 | 1 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Lack of access to site during covid | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Personal problems | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Milestone | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO |
|---|---|---|
| Started | 41 | 43 |
| Completed | 35 | 41 |
| Not completed | 6 | 2 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Could not cope with kafo after c-brace | 0 | 1 |
The Berg Balance Scale is a 14-item scale designed to measure static and dynamic balance in adults in a clinical setting. The range in score for the BBS is 0 to 56, with higher scores indicating better balance. Points for each item are deducted if the time or distance requirements are not met, the patient's performance requires supervision, or the patient requires assistance from support or examiner.
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Primary Efficacy: Berg Balance Scale (BBS) | 33.6 ± 11.0 | 37.3 ± 10.5 | 42.0 ± 9.1 |
Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Activity-specific Balance Confidence (ABC) Scale | 53.1 ± 19.2 | 51.0 ± 18.3 | 62.3 ± 19.5 |
An 8-item test used to assess balance during walking tasks. It has a maximum score of 24 with each item being scored 0-3. A higher score indicates greater balance, and subjects lose a a point on all items for which an assistive device is needed.
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Dynamic Gait Index (DGI) | 12.3 ± 3.3 | 13.4 ± 3.2 | 15.7 ± 3.3 |
Distance walked in 6 minutes over 12-meter back-and-forth pathway as a measure of functional exercise capacity.
| meters | Baseline | KAFO | C-Brace |
|---|---|---|---|
| 6-minute Walk Test | 204.9 ± 73.9 | 213.7 ± 80.9 | 226.0 ± 84.3 |
A 14-point ordinal scale (0 - 13) used to assess different gait patterns during descent of stairs. The range of total scores for the SAI is from 0 to 26, with a higher score indicating a more normative gait pattern and needing less assistance.
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Stair Assessment Index (SAI) - Down | 4 ± 3.3 | 4.5 ± 3.5 | 6 ± 4.2 |
Frequency of falling by using C-Brace compared to KAFO/SCO as measured by the number of falls in 3-month period by recollection at baseline and recorded in a Falls Diary during home-use periods
| number of falls in a three month period | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Frequency of Falling | 4.9 ± 20.1 | 4.0 ± 16.8 | 1.1 ± 3.3 |
Two questions on patients' fear of falling indoors and outdoors based on an 11-point scale (0 = no fear, 10 = max. fear). The total score will range from 0 to 20, with 20 being maximum fear of falling.
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Fear of falling indoors | 3.3 ± 2.9 | 3.3 ± 2.8 | 2.2 ± 2.6 |
| Fear of falling outdoors | 5.5 ± 3.0 | 5.2 ± 2.9 | 4.4 ± 3.0 |
Proportion of subjects having reported falling more than once will be compared between KAFO and C-Brace home-use periods
| Participants | KAFO | C-Brace |
|---|---|---|
| Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO | 25 | 12 |
11 items measuring satisfaction regarding perceived physical functioning, and social and emotional life. Higher scores represent higher levels of participation. The range of the adjusted total score is 0 to 100.
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Reintegration to Normal Living (RNL) Index Questionnaire | 71.5 ± 19.8 | 71.7 ± 17.6 | 74.0 ± 19.8 |
Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). The raw score is then aggregated and normalized based on region to a 0 to 1 scale (where 0 represents maximum issues and 1 represents no problems).
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| EQ-5D-5L | 0.71 ± 0.19 | 0.72 ± 0.19 | 0.74 ± 0.18 |
25-item questionnaire to evaluate at-work disability and productivity loss under four sub-scales: time demands, physical demands, mental/interpersonal demands, and output demands. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time).
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Mental/Interpersonal | 86.1 ± 13.3 | 88.4 ± 11.5 | 91.0 ± 13.7 |
| Output | 82.0 ± 17.9 | 81.9 ± 17.0 | 84.6 ± 17.3 |
| Physical | 37.5 ± 24.8 | 34.5 ± 23.3 | 24.3 ± 18.8 |
| Time | 79.2 ± 20.1 | 78.3 ± 24.6 | 79.8 ± 19.8 |
A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services. Three of the five domains will be administered: lower extremity functional status (20 items, score ranges from 0 - 80, with high score being easier), health-related quality of life index (23 items, score ranges from 0 - 92, with higher score being better) and satisfaction with device (11 items, score ranges from 11 - 55, with higher score being more satisfaction) scales. The domains of upper limb functional measure and satisfaction with service are not applicable in this study.
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Quality of Life | 56.6 ± 7.3 | 56.9 ± 6.9 | 58.0 ± 8.0 |
| Lower Extremity Functional Status | 45.3 ± 6.2 | 46.6 ± 6.3 | 48.8 ± 6.3 |
| Satisfaction with Device | 49.8 ± 10.5 | 50.6 ± 9.7 | 51.3 ± 13.7 |
36-item scale constructed to survey health status and quality of life. It assesses eight health concept scales: physical functioning, role functioning/physical, role functioning/emotional, energy/fatigue, emotional well-being, social functioning, pain and general health. Each scale score ranges from 0 to 100 with 100 being the highest (better) score.
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Emotional Wellbeing | 76.2 ± 16.4 | 75.5 ± 16.3 | 79.2 ± 15.16 |
| Energy/Fatigue | 52.2 ± 21.3 | 52.3 ± 20.3 | 56.8 ± 20.1 |
| General Health | 54.1 ± 22.2 | 54.2 ± 23.8 | 58.2 ± 23.8 |
| Health Change | 47.4 ± 24.2 | 48.0 ± 26.0 | 56.5 ± 26.4 |
| Pain | 55.6 ± 25.3 | 57.4 ± 24.9 | 59.5 ± 26.7 |
| Physical Functioning | 29.7 ± 22.6 | 31.1 ± 23.8 | 44.3 ± 23.3 |
| Role limitations due to emotional problems | 78.1 ± 36.9 | 82.2 ± 34.3 | 86.1 ± 28.8 |
| Role limitations due to physical health | 36.5 ± 39.7 | 44.9 ± 43.2 | 51.0 ± 41.2 |
| Social Functioning | 74.2 ± 23.0 | 75.1 ± 25.0 | 77.3 ± 24.4 |
12-item instrument used to assess satisfaction with a specific assistive device. Each questions is rated on a 5-point scale, with 1=not satisfied at all and 5=very satisfied. The first 8 questions comprise the Device subscale and the last 4, the Services subscale. Each subscale and the total score are presented as averages ranging from 1 to 5, with higher scores representing greater satisfaction.
| score on a scale | Baseline | KAFO | C-Brace |
|---|---|---|---|
| Device | 4.05 ± 0.67 | 4.05 ± 0.72 | 4.00 ± 0.63 |
| Service | 4.60 ± 0.64 | 4.66 ± 0.70 | 4.79 ± 0.42 |
| Total | 4.23 ± 0.59 | 4.27 ± 0.64 | 4.27 ± 0.49 |
Two questions asking how the specific orthoses affected activities they enjoy and their quality of life. Each question is on a 5-point scale, with 1=much worse and 5=much better.
| units on a scale | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO |
|---|---|---|
| To what extent has the C-Brace enabled you to engage in the activities that you enjoy? | 4 (3 to 4) | 4 (3.75 to 5) |
| To what extent has the C-Brace impacted your quality of life? | 4 (3 to 4.5) | 4 (4 to 5) |
Collected over For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KAFO/SCO | 0/102 (0%) | 10/102 (9.8%) | 66/102 (64.7%) |
| C-Brace | 2/88 (2.3%) | 6/88 (6.8%) | 57/88 (64.8%) |
| Event | KAFO/SCO | C-Brace |
|---|---|---|
| Prostate cancerReproductive system and breast disorders | 0/57 | 1/46 |
| Intestinal haemorrhageGastrointestinal disorders | 0/102 | 1/88 |
| Chest PainGeneral disorders | 1/102 | 1/88 |
| Foot fractureInjury, poisoning and procedural complications | 0/102 | 1/88 |
| SyncopeNervous system disorders | 0/102 | 1/88 |
| Deep Vein ThrombosisVascular disorders | 1/102 | 1/88 |
| CholecystolithiasisHepatobiliary disorders | 1/102 | 0/88 |
| COVID-19Infections and infestations | 1/102 | 0/88 |
| Hip FractureInjury, poisoning and procedural complications | 1/102 | 0/88 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 1/102 | 0/88 |
| Event | KAFO/SCO | C-Brace |
|---|---|---|
| Battery holder defectProduct Issues | 1/2 | — |
| BeepingProduct Issues | 1/2 | 3/88 |
| Injurious FallInjury, poisoning and procedural complications | 21/102 | 10/88 |
| Unexpected mode switchProduct Issues | 1/7 | 4/88 |
| Pain in legMusculoskeletal and connective tissue disorders | 8/102 | 8/88 |
| Skin AbrasionSkin and subcutaneous tissue disorders | 3/102 | 8/88 |
| Back PainMusculoskeletal and connective tissue disorders | 8/102 | 7/88 |
| Joint MalfunctionProduct Issues | 7/102 | 2/88 |
| Pain in footMusculoskeletal and connective tissue disorders | 3/102 | 6/88 |
| Increased fall frequencyGeneral disorders | 6/102 | 1/88 |
Intention to Treat Group
| Age, Continuous(years) | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO | Total |
|---|---|---|---|
| Mean | 56.1 ± 15.2 | 55.4 ± 12.4 | 55.8 ± 13.8 |
| Sex: Female, Male(Participants) | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO | Total |
|---|---|---|---|
| Female | 26 | 19 | 45 |
| Male | 26 | 31 | 57 |
| Race/Ethnicity, Customized(Participants) | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO | Total |
|---|---|---|---|
| Caucasian | 40 | 38 | 78 |
| Asian | 6 | 6 | 12 |
| Black or African American | 2 | 2 | 4 |
| Other | 4 | 4 | 8 |
| Region of Enrollment(participants) | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO | Total |
|---|---|---|---|
| Netherlands | 4 | 3 | 7 |
| Austria | 0 | 1 | 1 |
| United States | 20 | 22 | 42 |
| Germany | 28 | 24 | 52 |
| Body Weight(kg) | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO | Total |
|---|---|---|---|
| Mean | 77.5 ± 15.8 | 82.8 ± 16.3 | 80.1 ± 16.2 |
| Height(cm) | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO | Total |
|---|---|---|---|
| Mean | 170.1 ± 11.3 | 170.3 ± 11.3 | 170.2 ± 11.2 |
| Work/employment status(Participants) | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO | Total |
|---|---|---|---|
| Employed | 17 | 25 | 42 |
| Retired | 22 | 21 | 43 |
| Unemployed | 13 | 4 | 17 |
| Side/bilateral orthosis(Participants) | KAFO/SCO, Then C-Brace | C-Brace, Then KAFO/SCO | Total |
|---|---|---|---|
| Right | 18 | 23 | 41 |
| Left | 26 | 21 | 47 |
| Bilateral | 8 | 6 | 14 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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