Assessment of HydroxyColl Bone Graft Substitute in High Tibial Osteotomy Wedge Grafting.

NCT03601130 | Unknown

• 1 other identifier: SC100.2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to demonstrate the safety and efficacy of Hydroxycoll bone graft substitute when used in the treatment of patients undergoing surgical treatment for varus mis-alignment in medial unicompartmental osteoarthritis of the knee. HydroxyColl bone graft substitute will be evaluated when utilized in Open Wedge High Tibial Osteotomy with medial plate fixation. Its safety profile will be evaluated as defined by the number of reported adverse events.

Conditions

Osteoarthritis, Knee

Keywords

osteotomy; osteoarthritis; bone graft substitute

Outcome Measures

Primary Outcomes (18)

• Radiological Healing

  clinical assessment of healing based on radiological observations by a member of the clinical team

  Week 6

• Radiological Healing

  clinical assessment of healing based on radiological observations by a member of the clinical team

  Week 12

• Radiological Healing

  clinical assessment of healing based on radiological observations by a member of the clinical team

  Week 52

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  Day 0

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  Day 1

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  Week 6

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  Week 12

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  Week 52

• EQ5D Score

  Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.

  Day 0

• EQ5D Score

  Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.

  Day 1

• EQ5D Score

  Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.

  Week 6

• EQ5D Score

  Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.

  Week 12

• EQ5D Score

  Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.

  Week 52

• VAS Score

  Patient reported outcomes relating to pain. Visual analog scale \[VAS\] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length \[both the gradations are used\]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[on 100-mm scale\].

  Day 0

• VAS Score

  Patient reported outcomes relating to pain. Visual analog scale \[VAS\] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length \[both the gradations are used\]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[on 100-mm scale\].

  Day 1

• VAS Score

  Patient reported outcomes relating to pain. Visual analog scale \[VAS\] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length \[both the gradations are used\]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[on 100-mm scale\].

  Week 6

• VAS Score

  Patient reported outcomes relating to pain. Visual analog scale \[VAS\] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length \[both the gradations are used\]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[on 100-mm scale\].

  Week 12

• VAS Score

  Patient reported outcomes relating to pain. Visual analog scale \[VAS\] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length \[both the gradations are used\]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[on 100-mm scale\].

  Week 52

Secondary Outcomes (5)

• Safety outcome based on clinical assessment of the adverse events reported during the trial.

  Day 0

• Safety outcome based on clinical assessment of the adverse events reported during the trial

  Day 1

• Safety outcome based on clinical assessment of the adverse events reported during the trial

  Week 6

• Safety outcome based on clinical assessment of the adverse events reported during the trial

  Week 12

• Safety outcome based on clinical assessment of the adverse events reported during the trial

  Week 52

Study Arms (2)

No Bone Graft

OTHER

Open Wedge High Tibial Osteotomy with medial plate fixation (without bone grafting)

Device: DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)

HydroxyColl Bone Graft Substitute

ACTIVE COMPARATOR

Open Wedge High Tibial Osteotomy with medial plate fixation (with bone grafting) using Hydroxycoll bone graft substitute.

Device: HydroxyColl Bone Graft Substitute; Device: DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)

Interventions

HydroxyColl Bone Graft Substitute DEVICE

The intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) with the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute.

HydroxyColl Bone Graft Substitute

DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) DEVICE

The intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) without the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute.

HydroxyColl Bone Graft Substitute; No Bone Graft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give written informed consent to participate in this study
• Both male and females who will be admitted to the hospital for treatment of varus mis-alignment in medial unicompartmental osteoarthritis of the knee of the degree to which the surgeon deems it necessary to include a bone grafting procedure
• Kellgren-Lawrence grade 1-4
• Ability and willingness to comply with all study requirements

You may not qualify if:

• History or presence of the following conditions: known sensitivity to bovine collagen or hydroxyapatite materials; diabetes, immune-compromised, vascular disease, metabolic/systemic bone disorder, osteomyelitis
• Failure to provide written informed consent
• Severe acute or chronic medical illness, including symptomatic cardiovascular disease
• Weight less than 40 kilograms
• Any clinically significant abnormality at the time of submission, in the judgement of the investigator would preclude safe completion of the study
• Any use of estrogens, estrogen-progestin therapy, selective estrogens receptor modulators (SERMs) or calcitonin within 3 months, and use of bisphosphonates or recombinant PTH 1-34, 1-84 or other PTH fragments/analogues within the last 6 months
• History of alcohol or drug abuse within the last year
• History of non-compliance to medical regimens and/or patients who are considered potentially unreliable
• Significant psychiatric disorder or behaviour
• Presence of any concomitant condition which, in the opinion of the investigator or the sponsor, may interfere with the interpretation of efficacy and safety data gathered in this study including chronic infections
• Chronic or \>7 days concomitant use of oral corticosteroids within 1 month prior to screening
• Regular smoker (more than 10 cigarettes per day) for the last 12 months
• Participation in another interventional orthopaedic clinical trial within 1 month of the beginning of this study

Sponsors & Collaborators

• SurgaColl Technologies Limited: lead

Study Sites (1)

Basingstoke & North Hampshire Hospital

Basingstoke, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael Risebury, MA MBBS FRCS

  Hampshire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angie Dempster

CONTACT

+44 (0)1256 315073; Angie.Dempster@hhft.nhs.uk

John P Gleeson, PhD

CONTACT

+353 (0)1 700; john.gleeson@surgacoll.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 26, 2018
• Study Start: April 30, 2018
• Primary Completion: December 27, 2019
• Study Completion: April 29, 2020
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

GB (1)